A Phase 1 interventional study of AZD8154 in Asthma, sponsored by AstraZeneca. Completed at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.
Among the 359 studies in Asthma by AstraZeneca, this one is the 163rd largest by enrollment of the 248 interventional ones that give a count, is one of 8 that started in 2018, is one of 46 in phase 1, and was the 235th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in China
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in China
Ages 18–75
AstraZeneca · Sites in United States, Argentina, Czechia and 4 more countries
Ages 4–11
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
359 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 52 · Phase 3 123 · Phase 4 23
First in 1996; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 78 is close to the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 175 across the 248 interventional studies, 500 across the 110 observational. Of the 330 that completed or were terminated, 129 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
13 of the studies in Asthma by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
| NCT07218172AstraZenecaCharacterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B) | 2026-11-30 |
Add all 13 to your calendar (.ics) → With an account.
Among the 359 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a Phase 1, first in human (FiH) study, consisting of 3 parts (Part 1, Part 2, and Part 3) in healthy male and female participants of non-childbearing potential, performed at a single study center. Part 1 of this study will be a randomized, single-blind, placebo-controlled, single ascending dose (SAD) in healthy male and female participants of non-childbearing potential. Six dose levels of AZD8154 are planned to be investigated. Depending on emerging data, 1 to 2 additional dose levels may be added at the discretion of the Sponsor. Furthermore, one dose level will be repeated using the same formulation of AZD8154 but with a larger particle size (Part 1 only). Part 2 of this study will be a single cohort, open-label, 2-period, study to compare a single inhaled dose of AZD8154 (small particle size) nebuliser suspension with a single IV dose of AZD8154. Part 3 will be a single blind placebo controlled, multiple ascending doses (MAD) sequential design study in healthy male and/or female subjects of non childbearing potential conducted at a single center. Part 3:Three (3) inhaled dose levels of AZD8154 are planned to be investigated. Depending on the emerging data, up to 2 additional inhaled dose levels may be added at the discretion of the Sponsor.
This is a phase 1 study to assess the safety, tolerability and pharmacokinetics of AZD8154 following single and multiple ascending dose administration in healthy participants. This study will have 3 parts (Part 1, Part 2, and Part 3). Part 1 consists of six cohorts, each consisting of 8 participants. Depending on emerging PK and adverse event (AE) data, 1 to 2 additional inhaled dose levels, within the pre-specified dose range, may be added at the discretion of the Sponsor. One dose level cohort selected based on emerging data will be repeated using the same formulation of AZD8154 but with a larger particle size. The selected cohort (e.g., Cohort 5), referred to as the "Large Particle Size Cohort", will be dosed at the same dose level with a larger particle size after a minimum washout period of 7 to 14 days between each dose administration.
Small Particle Size Cohorts:
Within each cohort, 6 participants will be randomized to receive an inhaled dose of AZD8154 (small particle size) and 2 participants will be randomized to receive inhaled placebo. Dosing for each ascending dose cohort will proceed with 2 participants in a sentinel cohort, such that 1 participant will be randomized to receive placebo and 1 participant will be randomized to receive AZD8154 (small particle size).
Large Particle Size Cohort:
For the selected Large Particle Size Cohort, the 6 participants that received AZD8154 (small particle size) will return for a second Treatment Period after a minimum washout period of 7 to 14 days. All 6 participants will receive an inhaled dose of AZD8154 (large particle size), at the same dose level that they received AZD8154 (small particle size) in Treatment Period 1. The duration of the washout period is based on the predicted half-life of AZD8154 and was selected to diminish the impact of carry-over effects from the first Treatment Period.
Part 2: Part 2 of this study will be a single cohort. One cohort consisting of 6 participants will be enrolled into Part 2 of the study. All subjects will receive AZD8154 IV in Treatment Period 1 and then after washout, receive inhaled AZD8154 (small particle size) in Treatment Period 2. Intravenous dosing will proceed with 1 participant in a sentinel cohort, no sentinel dosing will be done in the inhaled dosing period.
Part 3: Three cohorts (MAD Cohort 1 to Cohort 3), each consisting of 8 participants, will participate in Part 3 of the study. Within each cohort, 6 participants will be randomized to receive an inhaled dose of AZD8154 and 2 participants will be randomized to receive inhaled placebo. Dosing for each ascending dose cohort will proceed with 2 participants in a sentinel cohort, such that 1 participant will be randomized to receive placebo and 1 participant will be randomized to receive AZD8154. In Part 3, participants will be randomized to receive an inhaled dose of AZD8154 nebuliser suspension or placebo. Three (3) inhaled dose levels of AZD8154 that are administered once daily are planned to be investigated. Based upon emerging PK and safety data in MAD Cohorts 1 to 3, up to 2 additional inhaled dose levels, within the pre-specified dose range, may also be added at the discretion of the Sponsor.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, defined as the following:
9.1. (ALT) and/or aspartate aminotransferase (AST) > the (ULN) laboratory range.
9.2. > 1.5 times the ULN laboratory range. 9.3. \< lower limit of normal (LLN). 9.4. Absolute lymphocyte count \< LLN. 9.5. Fasting plasma glucose > ULN. 9.6. Triglycerides > ULN.
Abnormal vital signs, after 5 minutes supine rest, defined as any of the following:
11.1. Systolic BP \< 90 mmHg or > 140 mmHg. 11.2. Diastolic BP \< 50 mmHg or > 90 mmHg. 11.3. Heart rate \< 50 or > 90 beats per minute (bpm).
Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead safety and any clinically important abnormalities in the 12-Lead dECG as considered by the Investigator that may interfere with the interpretation of corrected for heart rate using Fridericia's formula (QTcF) interval changes, including abnormal ST-T-wave morphology, particularly in the CSP defined primary lead for dECG analysis or left ventricular hypertrophy.
12.1. Prolonged QTcF > 450 ms or shortened QTcF \< 340 ms or family history of long QT syndrome.
12.2. PR (PQ) interval shortening \< 120 ms (PR > 110 ms but \< 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
12.3. PR (PQ) interval prolongation (> 220 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation.
12.4. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. participants with QRS > 110 ms but \< 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation.
Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship or committed to an institution by governmental or juridical order.
In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 Participants will receive AZD8154 (single inhaled small particle dose 1) and 2 participants will receive placebo.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled small particle dose 2) and 2 participants will receive placebo.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled small particle dose 3) and 2 participants will receive placebo.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled small particle dose 4) and 2 participants will receive placebo.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled small particle dose 5) and 2 participants will receive placebo. Participants in this Cohort will return for a second Treatment Period after a minimum washout period of 7 to 14 days. All 6 subjects will receive an inhaled dose of AZD8154 (large particle size).
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled small particle dose 6) and 2 participants will receive placebo.
Drug: AZD8154
All participants in this cohort will receive single IV dose of AZD8154 in Treatment Period 1 and then after washout period, will receive inhaled AZD8154 (small particle size) in Treatment Period 2.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled dose 8) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (inhaled dose 8) or placebo once daily from Day 4 to Day 12.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled dose 9) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (Inhaled dose 9) or placebo once daily from Day 4 to Day 12.
Drug: AZD8154
6 Participants will receive AZD8154 (single inhaled dose 10) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (inhaled dose 10) or placebo once daily from Day 4 to Day 12.
Drug: AZD8154
SAD Part 1; 6 cohorts which receive single dosing. One cohort is invited back for large particle administration. Part 2; 1 cohort which receives IV dose and then inhaled administration of AZD8154. MAD Part 3; 3 cohorts will receive inhaled multiple dosing. Additional doses are provisional and could be adjusted based on the emerging data from the previous dose by the safety review committee (SRC).
Number of participants with adverse events (Part 1 & 2)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses; inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From Day-1 up to follow-up visit (6 days post final dose).
Number of participants with adverse events (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From Day-1 up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in 12-lead digital electrocardiography (ECG) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: At Treatment period (Days 1 to 3).
Number of participants with abnormal findings in 12-lead digital ECG (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: At Treatment Periods 1 and 2 (Days 1 to 3).
Number of participants with abnormal findings in 12-lead digital ECG (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: At Treatment period (Days 1 to 15).
Number of participants with abnormal pulse rate (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to the treatment period (Day -1, Days 1 to 3)
Number of participants with abnormal pulse rate (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening (Days -28 to -2) up to follow-up visit (6 ± 1 days post-dose)
Number of participants with abnormal pulse rate (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening (Days-28 to -2) up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in telemetry (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: At Treatment Period (Days 1 to 3).
Number of participants with abnormal findings in telemetry (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: At Treatment Periods 1 (Days 1 to 3) and 2 (Days 1 to 3 and Day 4).
Number of participants with abnormal findings in telemetry (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: At Treatment Period (Days 1 to 15)
Number of participants with abnormal hematology (Part 1 & Part 2)
To assess white blood cell count (WBC), red blood cell count (RBC), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count as a variable of safety and tolerability of AZD8154 following inhaled administration of single ascending doses and inhaled and intravenous (IV) administration of single doses to healthy participants to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal hematology (Part 3)
To assess white blood cell count (WBC), red blood cell count (RBC), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal blood pressure (systolic and diastolic) (Part 1 & Part 2)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses and inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to the treatment period (Day -1, Days 1 to 3)
Number of participants with abnormal blood pressure (systolic and diastolic) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in respiratory rate (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to the treatment period (Day -1, Days 1 to 3).
Number of participants with abnormal findings in respiratory rate (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal findings in respiratory rate (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal physical examination (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal physical examination (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal physical examination (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in oral body temperature (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment period (Day -1, Days 1 to 3).
Number of participants with abnormal findings in oral body temperature (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to Treatment Periods 1 and 2.
Number of participants with abnormal findings in oral body temperature (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Forced expiratory volume in 1 second (FEV1) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: At Days-28 to -2, Day -1, Days 1 to 3.
FEV1 (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: At Days-28 to -2, Day -1, Days 1 to 3, and follow-up visit (6 ± 1 days post-dose).
FEV1 (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: At Days-28 to -2, Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).
Forced vital capacity (FVC) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: At Days-28 to -2, Day -1, Days 1 to 3.
FVC (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: At Days-28 to -2, Day -1, Days 1 to 3, and follow-up visit (6 ± 1 days post-dose).
FVC (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: At Days-28 to -2, Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).
Number of participants with abnormal electrolytes (Part 1)
To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal electrolytes (Part 2)
To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal electrolytes (Part 3)
To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal hemoglobin (Hb) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal hemoglobin (Hb) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal hemoglobin (Hb) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal hematocrit (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal hematocrit (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal hematocrit (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal mean corpuscular volume (MCV) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal mean corpuscular volume (MCV) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal mean corpuscular volume (MCV) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal platelet count (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal platelet count (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal platelet count (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal reticulocytes absolute count (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal reticulocytes absolute count (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal reticulocytes absolute count (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Part 1 & Part 2)
The DLCO assessment will be performed in Part 1 of the study. The DLCO assessments will be performed in Part 2, only if emerging data in Part 1 indicates that it is needed. The DLCO should be performed according to the American thoracic society (ATS)/ European respiratory society (ERS) guidelines. Post dose DLCO will only be performed if a reduction is observed in FEV1 or FVC (≥ 12%) starting 6 hours after IMP administration.
Time frame: At Day -1, Days1 to 3 and follow-up visit (6 ± 1 days post-dose).
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Part 3)
The DLCO assessments will be performed in Part 2 and Part 3, only if emerging data in Part 1 indicates that it is needed. The DLCO should be performed according to the ATS/ERS guidelines. Post dose DLCO will only be performed if a reduction is observed in FEV1 or FVC (≥ 12%) starting 6 hours after IMP administration.
Time frame: At Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).
Number of participants with abnormal clinical chemistry (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal clinical chemistry (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal clinical chemistry (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal urinalysis (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The laboratory variables to be measured are: protein, glucose, and blood.
Time frame: From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal urinalysis (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The laboratory variables to be measured are: protein, glucose, and blood.
Time frame: From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal urinalysis (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The laboratory variables to be measured are: protein, glucose, and blood.
Time frame: From screening up to follow-up visit (7-10 days post final dose).
Observed maximum plasma concentration (Cmax)
To assess the Cmax of AZD8154 following inhaled administration of single ascending doses and intravenous (IV) doses of AZD8154 in healthy participants and to study the influence of particle size on AZD8154 PK parameters, to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
To assess the tmax of AZD8154 following inhaled administration of single ascending doses, IV doses of AZD8154, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Terminal elimination rate constant (λz)
To assess the λz of AZD8154 following inhaled and IV doses of AZD8154, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz)
To assess the t½λz of AZD8154 following inhaled administration of single ascending doses, IV doses of AZD8154, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under the plasma concentration time curve from time zero to 24 hours after dosing (AUC(0 24))
To assess the AUC(0 24) of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under the plasma concentration curve from time zero to the time of last quantifiable analyte concentration (AUClast)
To assess the AUClast of AZD8154 following inhaled administration of single ascending doses and IV doses of AZD8154, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under plasma concentration time curve from time zero extrapolated to infinity (AUC)
To assess the AUC of AZD8154 following inhaled administration of single ascending doses and IV doses of AZD8154, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To assess the CL/F of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Mean residence time of the unchanged drug in the systemic circulation (MRT)
To assess the MRT of AZD8154 following inhaled administration of single ascending doses and IV doses of AZD8154, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Volume of distribution at terminal phase (intravenous dosing) (Vz)
To assess the Vz of AZD8154 following IV administration.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To assess the Vz/F of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under the plasma concentration time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)
To assess the AUClast/D of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under the plasma concentration time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)
To assess the AUC/D of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Observed maximum plasma concentration divided by the dose administered (Cmax/D)
To assess the Cmax/D of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Time of last quantifiable plasma concentration (tlast)
To assess the tlast of AZD8154 following inhaled administration of single ascending doses, inhaled administration of single doses in healthy participants, and to study the influence of particle size on AZD8154 PK parameters.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Total body clearance of drug from plasma after intravascular administration (CL)
To assess the CL of AZD8154 following IV doses of AZD8154.
Time frame: At treatment period [Days 1 to 3]
Volume of distribution at steady state from a systemic dose (Vss)
To assess the Vss of AZD8154 following IV doses of AZD8154.
Time frame: At treatment period [Days 1 to 3]
Terminal half-life (t½)
To assess the t½ of AZD8154 following IV doses of AZD8154.
Time frame: At treatment period [Days 1 to 3]
Area under the plasma concentration time curve from time zero to 24 hours after dosing divided by the dose administered (AUC(0 24)/D)
To assess the AUC (0-24)/D of AZD8154 following inhaled administration of single ascending doses of AZD8154, inhaled doses of AZD8154, to study the influence of particle size on AZD8154 PK parameters, and to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under the concentration time curve in the dose interval (AUCτ)
To assess the AUCτ of AZD8154 following multiple dose pharmacokinetics of AZD8154 and to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period Days 1 to 12
Area under the concentration time curve in the dose interval divided by the dose administered (AUCτ/D)
To assess the AUCτ/D of AZD8154 following multiple dose pharmacokinetics of AZD8154 and to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period Days 1 to 12
Accumulation ratio based on AUCτ (Rac (AUC))
To assess the Rac (AUC) of AZD8154 following multiple dose pharmacokinetics of AZD8154 and to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period Days 1 to 12
Accumulation ratio based on Cmax (Rac (Cmax))
To assess the Rac (Cmax) of AZD8154 following multiple dose pharmacokinetics of AZD8154 and to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period Days 1 to 12
Temporal change parameter in systemic exposure [TCP (AUC)]
To assess the TCP (AUC) of AZD8154 following multiple dose pharmacokinetics of AZD8154 and to assess the time required to reach steady state, the degree of accumulation and the time dependency of the pharmacokinetics.
Time frame: At treatment period Days 1 to 12
Change from baseline concentration of 4 β hydroxy cholesterol
To assess the induction potential of AZD8154 on cytochrome P450 (CYP)3A by measuring 4 β hydroxy cholesterol at baseline and at steady state.
Time frame: Change from baseline
Mean absorption time (MAT)
To assess MAT of AZD8154 following inhaled doses of AZD8154.
Time frame: At treatment period [Days 1 to 3 & Day 4]
Fraction of administered dose systemically available (F)
To assess F of AZD8154 following inhaled doses of AZD8154.
Time frame: At treatment period [Days 1 to 3 & Day 4]
Plan to share: No
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Ran from Jul 2018 to primary completion in Jul 2019, 12 months.
Of 173 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 12 months is above that.
Counting every sponsor, half of 200 studies reached it within 6 months; a quarter within 3 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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