A Phase 1 interventional study of ATH-1105 and Placebo in Healthy Volunteers, sponsored by Athira Pharma. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Athira Pharma · Phase 1, Interventional, and Other
The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.
Athira Pharma is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Medical Conditions:
Any of the following:
Prior/concomitant therapy:
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
Part A: ATH-1105 administered once as an oral solution. Part B: ATH-1105 administered once daily as an oral solution for 10 days.
Drug: ATH-1105
Part A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution
Drug: Placebo
ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B.
Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Severity of Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
Time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Area under the plasma concentration time curve (AUC)
AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Maximum observed plasma concentration (Cmax)
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Time to maximum observed plasma concentration (Tmax)
Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Half-life (t1/2)
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Amount of IMP excreted unchanged in the urine (Ae)
Amount of IMP excreted unchanged in the urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
IMP Concentration in Cerebrospinal Fluid
Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose
Time frame: Will occur at calculated maximum plasma concentration.
Accumulation Ratio (AUC) of IMP in Urine
Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Accumulation Ratio (AUC) of IMP in Plasma
Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Nov 2024, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Athira Pharma