CompletedNCT03473236Updated Jun 9, 2020Results posted

Phase 1A Safety Trial of Inhaled PK10571 (GB002)

A Phase 1 interventional study of GB002 and Generic Dry Powder Inhaler in Safety Issues, sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Sep 2017, registered Mar 2018).

Phase: Phase 1
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.

Read the detailed description

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, two-part study in healthy adult males and females of non-childbearing potential. "Double-Blind" means neither the study subject nor the investigator knows if PK10571 or placebo is being given. "Placebo" means a capsule filled with a powder that does not contain the active drug, PK10571. Because the safety profile of PK10571 in humans is unknown and this is the first clinical study to assess PK10571 in humans, a single-ascending dose design will be used in Part A of the study going from a low dose to higher doses based on safety. Part B will be a multiple-ascending dose design to be run only after review of safety and measurement of drug levels in the blood from Part A.

In the single ascending dose study (Part A) up to five doses may be given to different groups of study subjects based on safety and measurement of drug levels in the blood. Subjects will be randomized into one dose cohort to receive either PK10571 or placebo. Within each cohort, 6 subjects will receive active drug and 2 subjects will receive placebo.

In the multiple ascending dose study (Part B), up to three doses of PK10571 will be tested. The daily dose will be administered daily for 7 days with close clinical monitoring. The dose for the first cohort of Part B will be determined by review of the safety and drug levels from Part A by the Safety Review Committee. The dose interval for the first cohort of Part B (i.e., once daily, twice daily, or up to three times daily) will be determined by review of the safety and drug levels in the blood from Part A by the Safety Review committee. Subsequent doses and dosing intervals will be determined by review of the safety and drug levels from the prior cohort.

Conditions studied

Safety Issues

In context

Lead sponsor

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Inclusion criteria

Males and females (if unable to become pregnant)
Age 18-55
(BMI) 18-32 kg/m\^2 and minimum weight of 50 kg (110 lbs)
Non-smoker
Ability to give
Ability to remain in study unit for duration of study and return for outpatient visits
Ability to use dry powder inhaler (DPI) effectively

(See full protocol for additional details.)

Exclusion criteria

Exclusion Criteria:

Hospitalization within the 6 months prior to the first dose of study treatment
History or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results
History or presence of active lung disease (i.e., asthma, [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis) or prior intubation
Currently uses an inhaler
History or presence of heart disease (i.e., prior myocardial infarction [MI], coronary artery disease, heart failure, hypertension, pulmonary hypertension, valve disease, atrial fibrillation, other arrhythmia, or prolonged syndrome)
History or presence of cancer (with the exception of basal cell skin cancer that has been effectively treated)
History of diabetes mellitus
History of thyroid disease other than hypothyroidism control with levothyroxine and documented normal thyroid-stimulating hormone (TSH)
History of tuberculosis, Lyme disease, or other chronic or opportunistic infection.
History of positive purified protein derivative (PPD) skin test, or positive PPD test at screening
Has a positive test for surface antigen, antibody, or (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection
History of smoking within the past 15 years
Is a female with a positive pregnancy test result, or who has the ability to become pregnant, or who is lactating
Has (FEV1) less than 80% predicted, forced vital capacity (FVC) ˂80% predicted, or resting oxygen saturation less than 97% on room air at screening or baseline
Upper respiratory infection within the 3 months prior to the first dose of medication
History of major bleeding or major surgical procedure of any type within 6 months prior to the first dose of medication
History of minor bleeding disorders such as epistaxis, rectal bleeding (spots of blood on toilet paper), and gingival bleeding within 3 months before the study treatment
History of bleeding disorder or coagulopathy
Females with history of dysfunctional uterine bleeding, including history of menorrhagia or metrorrhagia, unless subject has had a hysterectomy.
History of GI bleed
Has used any over-the-counter (OTC) medication, nutritional or dietary supplements, herbal preparations, or vitamins within 7 days prior to the first dose of medication
Has used any antiplatelet agents such as acetylsalicylic acid (ASA), nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel (or similar agent) or anti-coagulants within 7 days prior to the first dose of medication
Has used any prescription medication, except female hormonal replacement therapy, within 14 days prior to the first dose of study medication
Has been treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that in the Investigator's judgment may impact subject safety or the validity of the study results
History of peripheral vascular disease
History of or collagen vascular disease
History of sleep apnea
History of clinically significant allergy to medications
History of anaphylaxis
History of liver disease
History of alcohol or drug abuse
Prolonged QTc on 12-lead (i.e., QTc corrected using Fridericia's formula [QTcF] ˃450 msec), PR >210 msec, or QRS >110 msec at screening.
Evidence of prior MI on ECG; presence of atrial fibrillation on ECG; presence of pre-excitation, 2nd or 3rd degree heart block, or abnormal waveform morphology that would preclude accurate measurement of the QT interval duration or other clinically significant abnormalities
Chest x-ray reveals presence of infiltrate or other abnormality (mass, granuloma, fibrosis, pulmonary thickening, pleural effusion, pulmonary edema, wide mediastinum, cardiomegaly, or clinically significant increased interstitial markings)
History of neurologic disorder (i.e., multiple sclerosis, amyotrophic lateral sclerosis [ALS], cerebrovascular accident [CVA], transient ischemic attach [])
History of deep vein thrombosis or pulmonary embolus
History of clotting disorder
History of mental illness requiring drug treatment or hospitalization
History of renal failure or proteinuria (defined as 1+ proteinuria: ≥75 mg/dL on isolated urinalysis)
Test results greater than the (ULN) for , ALT, or total
Out of range results on the following coagulation tests: , prothrombin time (PT), or partial thromboplastin time (PTT)
Total cholesterol >250 mg/dL or triglycerides >300 mg/dL at screening (based on fasting lipid profile)
Estimated less than 60 mL/min
at screening of \<11.5 g/dl (if female subject) or \<12.5 g/dl (if male subject)
Has a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening. Note: Subjects with abnormal laboratory results not specifically excluded by this protocol may be enrolled if the Investigator deems the out-of-range values as not clinically significant
History of treatment with a kinase inhibitor
Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication
Has donated blood or plasma within 30 days prior to the first dose of study medication
Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication
Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine
Vital signs (measured sitting after 3 minutes rest) at screening that are not within the following ranges (inclusive): heart rate: 40-100 beats per minute [bpm]; systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once. Blood pressure will be measured in both arms at screening, with a 3-minute rest between each measurement. Predose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) prior to study drug administration. The Principal Investigator or designee will verify the eligibility of each subject with out-of-range vital signs and document approval prior to dosing
Significant difference (i.e., greater than 15 mmHg) between the systolic blood pressure in each arm at screening
History of lactose intolerance

Terms in these criteria, in plain language(18)

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.

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.

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.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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.

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.

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.

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

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.

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.

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.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 66 participants (actual)

Study arms

Experimental
Cohort 1A
Dose 1 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 2A
Dose 2 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 3A
Dose 3 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 4A
Dose 4 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 5A
Dose 5 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 1B
Dose 1 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 2B
Dose 2 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo
Experimental
Cohort 3B
Dose 3 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo.
Drug: GB002 · Device: Generic Dry Powder Inhaler · Drug: Placebo

Interventions

DrugGB002
Inhaled GB002
Also known as: PK10571
DeviceGeneric Dry Powder Inhaler
dry powder inhaler used for inhalation of active drug or placebo
DrugPlacebo
Inhaled placebo

What researchers measure

Primary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious AE (SAE) is one that, in the view of either the investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A TEAE is defined as any AE that has an onset on or after the first dose of study drug and before the end of study/end of treatment (EoS/ET) visit, or any pre-existing condition that has worsened in severity on or after the first dose of study drug and before the EoS/ET visit.
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Number of Participants With Vital Sign Findings Reported as TEAEs
Vital signs evaluated included blood pressure, pulse oximetry, respiratory rate, and temperature.
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Number of Participants With Clinically Significant Findings in Physical Examinations
Physical examination assessments included: physical exam for general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities, musculoskeletal and neurological.
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Number of Participants With Clinically Significant Changes From Baseline in ECG Data (Overall Interpretation)
12-lead electrocardiograms (ECG) assessments included heart rate, PR interval, QRS duration, QT interval, QTc interval, QTc interval corrected using Bazett's formula (QTcB), QTc interval corrected using Fridericia's formula (QTcF), RR interval.
Time frame: SAD: Baseline, Day 2, 24 hours; MAD: Baseline, Day 8, 24 hours
Number of Participants With Clinically Significant Abnormal Findings in Pulmonary Function Tests
Pulmonary function tests included forced vital capacity; forced expiratory volume in 1 second (FEV1); forced expiratory flow 25%-75% (FEF25-75); percent predicted forced vital capacity; percent predicted FEV1; and percent predicted FEF25-75.
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Pharmacokinetic (PK) Analysis of Inhaled GB002: Maximum Concentration (Cmax), SAD
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Time to Cmax (Tmax), SAD
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUClast), SAD
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Infinity (AUCinf), SAD
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Apparent Terminal Elimination Half-Life (t1/2), SAD
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance (CL/F), SAD
CL/F is based on nominal (scheduled) dose.
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Apparent Volume of Distribution (Vz/F), SAD
Vz/F is based on nominal (scheduled) dose.
Time frame: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Cmax After Dose 1, MAD
Time frame: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Tmax After Dose 1, MAD
Time frame: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Area Under the Curve From Time Zero to 24 Hours Postdose (AUC0-24), MAD
Time frame: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Trough Plasma Concentration (Ctrough), MAD
Time frame: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Accumulation Ratio (Rac) for Cmax After Dose 1, MAD
Time frame: Days 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Rac for AUC0-24, MAD
Time frame: Days 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Rac for Ctrough, MAD
Time frame: Days 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: t1/2, MAD
Time frame: Day 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance at Steady-State (CLss/F), MAD
Time frame: Day 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
PK Analysis of Inhaled GB002: Vz/F, MAD
Time frame: Day 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration

Other outcomes

Change From Baseline in White Blood Cell Count
Measurement of white blood cell count
Time frame: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Change From Baseline in Hemoglobin
Measurement of hemoglobin
Time frame: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Change From Baseline in Kidney Function Parameters
Measurement of blood urea nitrogen (BUN) and creatinine.
Time frame: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Change From Baseline in Liver Function Parameters
Measurement of liver function (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]).
Time frame: SAD: from baseline to 11 days, MAD: from baseline to 35 days

Results

Posted Feb 17, 2020

Participant flow

Participant flow — Overall Study
Milestone	SAD PK10571 (GB002) Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Started	10	6	6	6	6	7	6	6	7	6
Completed	10	6	6	6	6	6	6	6	6	6
Not completed	0	0	0	0	0	1	0	0	1	0
Withdrew: Withdrawal by subject	0	0	0	0	0	1	0	0	1	0

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious AE (SAE) is one that, in the view of either the investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A TEAE is defined as any AE that has an onset on or after the first dose of study drug and before the end of study/end of treatment (EoS/ET) visit, or any pre-existing condition that has worsened in severity on or after the first dose of study drug and before the EoS/ET visit.

Time frame:: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Any TEAE	2	1	2	1	2	1	5	4
Treatment Related TEAE	0	1	0	1	2	1	3	4
Severe TEAE	0	0	0	0	0	0	0	0
Serious Treatment Related TEAE	0	0	0	0	0	0	0	0
TEAE Leading to Early Termination	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Vital Sign Findings Reported as TEAEs

Vital signs evaluated included blood pressure, pulse oximetry, respiratory rate, and temperature.

Time frame:: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Reported as:: Count of participants · Participants

Number of Participants With Vital Sign Findings Reported as TEAEs
Participants	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Number of Participants With Vital Sign Findings Reported as TEAEs	0	0	0	0	0	0	0	0	1	0

PrimaryNumber of Participants With Clinically Significant Findings in Physical Examinations

Physical examination assessments included: physical exam for general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities, musculoskeletal and neurological.

Time frame:: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Findings in Physical Examinations
Participants	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Number of Participants With Clinically Significant Findings in Physical Examinations	0	0	0	0	0	0	0	0	0	1

PrimaryNumber of Participants With Clinically Significant Changes From Baseline in ECG Data (Overall Interpretation)

12-lead electrocardiograms (ECG) assessments included heart rate, PR interval, QRS duration, QT interval, QTc interval, QTc interval corrected using Bazett's formula (QTcB), QTc interval corrected using Fridericia's formula (QTcF), RR interval.

Time frame:: SAD: Baseline, Day 2, 24 hours; MAD: Baseline, Day 8, 24 hours
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Changes From Baseline in ECG Data (Overall Interpretation)
Participants	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Number of Participants With Clinically Significant Changes From Baseline in ECG Data (Overall Interpretation)	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Clinically Significant Abnormal Findings in Pulmonary Function Tests

Pulmonary function tests included forced vital capacity; forced expiratory volume in 1 second (FEV1); forced expiratory flow 25%-75% (FEF25-75); percent predicted forced vital capacity; percent predicted FEV1; and percent predicted FEF25-75.

Time frame:: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Abnormal Findings in Pulmonary Function Tests
Participants	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Number of Participants With Clinically Significant Abnormal Findings in Pulmonary Function Tests	0	0	0	0	0	0	0	0	0	0

PrimaryPharmacokinetic (PK) Analysis of Inhaled GB002: Maximum Concentration (Cmax), SAD

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · ng/mL

Pharmacokinetic (PK) Analysis of Inhaled GB002: Maximum Concentration (Cmax), SAD
ng/mL	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
Pharmacokinetic (PK) Analysis of Inhaled GB002: Maximum Concentration (Cmax), SAD	19.4 ± 41.32	51.7 ± 36.88	161 ± 33.12	184 ± 78.39	377 ± 32.94

PrimaryPK Analysis of Inhaled GB002: Time to Cmax (Tmax), SAD

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Median · hours

PK Analysis of Inhaled GB002: Time to Cmax (Tmax), SAD
hours	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
PK Analysis of Inhaled GB002: Time to Cmax (Tmax), SAD	0.0833 (0.0833 to 0.0833)	0.0500 (0.0500 to 0.183)	0.0500 (0.0500 to 0.0500)	0.0500 (0.0500 to 0.0500)	0.0833 (0.0833 to 0.0833)

PrimaryPK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUClast), SAD

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · h*ng/mL

PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUClast), SAD
h*ng/mL	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUClast), SAD	28.7 ± 35.19	60.6 ± 23.01	147 ± 19.51	214 ± 28.55	423 ± 44.51

PrimaryPK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Infinity (AUCinf), SAD

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · h*ng/mL

PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Infinity (AUCinf), SAD
h*ng/mL	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Infinity (AUCinf), SAD	28.9 ± 34.50	60.9 ± 22.90	147 ± 19.43	215 ± 28.48	423 ± 44.41

PrimaryPK Analysis of Inhaled GB002: Apparent Terminal Elimination Half-Life (t1/2), SAD

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · hours

PK Analysis of Inhaled GB002: Apparent Terminal Elimination Half-Life (t1/2), SAD
hours	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
PK Analysis of Inhaled GB002: Apparent Terminal Elimination Half-Life (t1/2), SAD	3.48 ± 25.72	3.08 ± 28.54	3.32 ± 12.68	4.41 ± 23.00	4.16 ± 20.35

PrimaryPK Analysis of Inhaled GB002: Apparent Total Plasma Clearance (CL/F), SAD

CL/F is based on nominal (scheduled) dose.

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · L/h

PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance (CL/F), SAD
L/h	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance (CL/F), SAD	130 ± 34.50	123 ± 22.90	102 ± 19.43	140 ± 28.48	113 ± 44.41

PrimaryPK Analysis of Inhaled GB002: Apparent Volume of Distribution (Vz/F), SAD

Vz/F is based on nominal (scheduled) dose.

Time frame:: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · L

PK Analysis of Inhaled GB002: Apparent Volume of Distribution (Vz/F), SAD
L	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD
PK Analysis of Inhaled GB002: Apparent Volume of Distribution (Vz/F), SAD	650 ± 25.86	548 ± 24.12	489 ± 18.33	889 ± 32.24	681 ± 44.68

PrimaryPK Analysis of Inhaled GB002: Cmax After Dose 1, MAD

Time frame:: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · ng/ml

PK Analysis of Inhaled GB002: Cmax After Dose 1, MAD
ng/ml	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Day 1	146 ± 35.4	229 ± 55.1	571 ± 26.0
Day 7	193 ± 27.0	246 ± 49.0	528 ± 61.8

PrimaryPK Analysis of Inhaled GB002: Tmax After Dose 1, MAD

Time frame:: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Median · hours

PK Analysis of Inhaled GB002: Tmax After Dose 1, MAD
hours	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Day 1	0.0833 (0.0833 to 0.0833)	0.0833 (0.0833 to 0.117)	0.0833 (0.0833 to 0.0833)
Day 7	0.0833 (0.0833 to 0.0833)	0.0833 (0.0833 to 0.0833)	0.0833 (0.0833 to 0.0833)

PrimaryPK Analysis of Inhaled GB002: Area Under the Curve From Time Zero to 24 Hours Postdose (AUC0-24), MAD

Time frame:: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · h*ng/mL

PK Analysis of Inhaled GB002: Area Under the Curve From Time Zero to 24 Hours Postdose (AUC0-24), MAD
h*ng/mL	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Day 1	355 ± 25.9	870 ± 38.1	1690 ± 39.6
Day 7	462 ± 13.6	827 ± 20.2	1870 ± 42.2

PrimaryPK Analysis of Inhaled GB002: Trough Plasma Concentration (Ctrough), MAD

Time frame:: Days 1 and 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · h*ng/mL

PK Analysis of Inhaled GB002: Trough Plasma Concentration (Ctrough), MAD
h*ng/mL	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Day 1	1.27 ± 65.4	2.60 ± 55.3	3.83 ± 30.4
Day 7	2.11 ± 51.9	2.54 ± 26.0	4.29 ± 24.7

PrimaryPK Analysis of Inhaled GB002: Accumulation Ratio (Rac) for Cmax After Dose 1, MAD

Time frame:: Days 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · ratio

PK Analysis of Inhaled GB002: Accumulation Ratio (Rac) for Cmax After Dose 1, MAD
ratio	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
PK Analysis of Inhaled GB002: Accumulation Ratio (Rac) for Cmax After Dose 1, MAD	1.32 ± 27.3	1.13 ± 24.9	0.925 ± 39.7

PrimaryPK Analysis of Inhaled GB002: Rac for AUC0-24, MAD

Time frame:: Days 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · ratio

PK Analysis of Inhaled GB002: Rac for AUC0-24, MAD
ratio	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
PK Analysis of Inhaled GB002: Rac for AUC0-24, MAD	1.30 ± 25.6	0.985 ± 23.5	1.11 ± 16.8

PrimaryPK Analysis of Inhaled GB002: Rac for Ctrough, MAD

Time frame:: Days 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · ratio

PK Analysis of Inhaled GB002: Rac for Ctrough, MAD
ratio	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
PK Analysis of Inhaled GB002: Rac for Ctrough, MAD	1.66 ± 27.1	0.844 ± 41.0	1.12 ± 19.2

PrimaryPK Analysis of Inhaled GB002: t1/2, MAD

Time frame:: Day 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · hours

PK Analysis of Inhaled GB002: t1/2, MAD
hours	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
PK Analysis of Inhaled GB002: t1/2, MAD	4.41 ± 7.04	4.68 ± 18.2	5.75 ± 22.4

PrimaryPK Analysis of Inhaled GB002: Apparent Total Plasma Clearance at Steady-State (CLss/F), MAD

Time frame:: Day 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · L/h

PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance at Steady-State (CLss/F), MAD
L/h	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance at Steady-State (CLss/F), MAD	77.9 ± 13.55	87.1 ± 20.17	76.9 ± 42.25

PrimaryPK Analysis of Inhaled GB002: Vz/F, MAD

Time frame:: Day 7: 0 hour (predose), and then at 3, 10, 20, 30, 40 minutes, and 1, 2, 4, 8, 12, 24, 36, and 48 hours after the start of study treatment administration
Reported as:: Geometric mean · L

PK Analysis of Inhaled GB002: Vz/F, MAD
L	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
PK Analysis of Inhaled GB002: Vz/F, MAD	495 ± 9.46	588 ± 18.55	604 ± 29.81

Other pre-specifiedChange From Baseline in White Blood Cell Count

Measurement of white blood cell count

Time frame:: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Reported as:: Mean · 10^9 cells/L

Change From Baseline in White Blood Cell Count
10^9 cells/L	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Change From Baseline in White Blood Cell Count	0.42 ± 1.212	-0.07 ± 1.417	-0.25 ± 1.334	-0.93 ± 1.694	-0.75 ± 1.294	-0.16 ± 0.875	-0.28 ± 0.768	0.27 ± 0.922	0.65 ± 1.176	-0.05 ± 0.689

Other pre-specifiedChange From Baseline in Hemoglobin

Measurement of hemoglobin

Time frame:: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Reported as:: Mean · g/dL

Change From Baseline in Hemoglobin
g/dL	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Change From Baseline in Hemoglobin	0.08 ± 0.573	-0.62 ± 0.631	-0.50 ± 0.447	-0.30 ± 0.721	0.00 ± 0.410	-0.53 ± 0.599	-0.27 ± 0.683	-1.13 ± 0.723	-1.13 ± 0.314	-0.48 ± 0.512

Other pre-specifiedChange From Baseline in Kidney Function Parameters

Measurement of blood urea nitrogen (BUN) and creatinine.

Time frame:: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Reported as:: Mean · mg/dL

Change From Baseline in Kidney Function Parameters
mg/dL	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
Change of Urea Nitrogen (BUN) Concentration	-1.50 ± 3.689	-0.17 ± 2.787	0.83 ± 2.994	-0.17 ± 2.994	-0.33 ± 5.317	2.29 ± 2.289	0.00 ± 4.050	0.83 ± 1.722	-1.67 ± 1.966	-0.33 ± 3.724
Change of Creatinine Concentration	-0.01 ± 0.099	0.03 ± 0.052	0.02 ± 0.075	0.00 ± 0.089	0.03 ± 0.151	-0.01 ± 0.069	-0.03 ± 0.052	-0.07 ± 0.082	0.10 ± 0.253	-0.02 ± 0.041

Other pre-specifiedChange From Baseline in Liver Function Parameters

Measurement of liver function (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]).

Time frame:: SAD: from baseline to 11 days, MAD: from baseline to 35 days
Reported as:: Mean · U/L

Change From Baseline in Liver Function Parameters
U/L	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
AST	0.40 ± 3.098	-1.17 ± 5.269	2.50 ± 2.811	1.17 ± 4.750	0.17 ± 2.401	-1.29 ± 2.563	-1.17 ± 3.125	-0.67 ± 3.077	1.17 ± 7.782	-4.17 ± 3.430
ALT	-0.10 ± 7.203	-0.50 ± 6.025	1.17 ± 1.472	-0.17 ± 2.563	0.67 ± 3.204	-1.14 ± 4.634	-2.83 ± 7.653	-0.50 ± 3.886	3.50 ± 13.096	-2.17 ± 4.997

Adverse events

Collected over SAD: from baseline to day 11, MAD: from baseline to day 35. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SAD GB002 Placebo QD	0/10 (0%)	0/10 (0%)	0/10 (0%)
SAD GB002 3.75 mg QD	0/6 (0%)	0/6 (0%)	0/6 (0%)
SAD GB002 7.5 mg QD	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
SAD GB002 15 mg QD	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
SAD GB002 30 mg QD	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
SAD GB002 48 mg QD	0/7 (0%)	0/7 (0%)	1/7 (14.3%)
MAD GB002 Placebo BID/TID	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
MAD GB002 18 mg BID	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
MAD GB002 24 mg TID	0/7 (0%)	0/7 (0%)	5/7 (71.4%)
MAD GB002 48 mg TID	0/6 (0%)	0/6 (0%)	4/6 (66.7%)

Most frequent other events

Showing 10 of 23

Most frequent other events
Event	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID
NightmarePsychiatric disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	0/6	0/7	3/6
NeutropeniaBlood and lymphatic system disorders	0/10	0/6	1/6	0/6	0/6	0/7	0/6	0/6	0/7	1/6
PalpitationsCardiac disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	0/6	0/7	1/6
TinnitusEar and labyrinth disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	0/6	0/7	1/6
Abdominal PainGastrointestinal disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	0/6	0/7	1/6
VomitingGastrointestinal disorders	0/10	0/6	0/6	1/6	0/6	0/7	0/6	0/6	0/7	0/6
Application site erythemaGeneral disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	0/6	0/7	1/6
MyalgiaMusculoskeletal and connective tissue disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	0/6	0/7	1/6
Neck PainMusculoskeletal and connective tissue disorders	0/10	0/6	0/6	0/6	0/6	0/7	0/6	1/6	0/7	0/6
DizzinessNervous system disorders	0/10	0/6	0/6	0/6	0/6	0/7	1/6	0/6	1/7	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
Mean	42.4 ± 7.72	39.0 ± 7.54	36.8 ± 10.34	38.5 ± 8.78	39.5 ± 6.28	35.4 ± 9.59	33.3 ± 11.31	49.3 ± 4.13	31.7 ± 8.83	41.0 ± 6.10	38.8 ± 9.06

Sex: Female, Male
Sex: Female, Male(Participants)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
Female	4	3	3	4	3	3	2	4	3	3	32
Male	6	3	3	2	3	4	4	2	4	3	34

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
Hispanic or Latino	6	5	3	4	3	4	4	5	5	3	42
Not Hispanic or Latino	4	1	3	2	3	3	2	1	2	3	24
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	1	0	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0
Black or African American	2	1	1	1	3	2	0	3	2	2	17
White	8	5	5	5	3	5	5	3	5	4	48
More than one race	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
United States	10	6	6	6	6	7	6	6	7	6	66

Height
Height(cm)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
Mean	172.52 ± 12.156	165.82 ± 10.699	171.03 ± 14.785	169.30 ± 6.427	172.58 ± 16.351	165.84 ± 11.783	169.22 ± 11.468	162.27 ± 8.190	164.43 ± 9.351	167.45 ± 10.418	168.23 ± 11.220

Bodyweight
Bodyweight(kg)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
Mean	79.55 ± 8.023	77.77 ± 15.075	70.37 ± 16.170	76.33 ± 8.091	90.68 ± 18.925	70.37 ± 6.307	81.27 ± 15.944	74.58 ± 12.449	72.24 ± 8.247	65.45 ± 12.565	75.95 ± 13.255

BMI
BMI(kg/m^2)	SAD GB002 Placebo QD	SAD GB002 3.75 mg QD	SAD GB002 7.5 mg QD	SAD GB002 15 mg QD	SAD GB002 30 mg QD	SAD GB002 48 mg QD	MAD GB002 Placebo BID/TID	MAD GB002 18 mg BID	MAD GB002 24 mg TID	MAD GB002 48 mg TID	Total
Mean	26.85 ± 2.804	28.07 ± 3.195	23.88 ± 3.407	26.60 ± 1.932	30.18 ± 1.520	25.86 ± 3.574	28.25 ± 3.384	28.18 ± 2.712	26.89 ± 3.609	23.20 ± 2.589	26.79 ± 3.352

Study locations

1 site

Phase 1 Unit
San Antonio, Texas 00000, United States

References and documents

Study documents

Study protocol ↗ · Jul 31, 2018
Statistical analysis plan ↗ · Aug 16, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Dec 2018, 14 months.

Results were first posted in Feb 2020, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 8, 2018
First posted: Mar 22, 2018
StartActual: Sep 6, 2017
Primary completionActual: Dec 3, 2018
CompletionActual: Dec 3, 2018
Results first posted: Feb 17, 2020
Last update: Jun 9, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03473236
Lead sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborators: Pulmokine Inc., Worldwide Clinical Trials
Responsible party: Sponsor
First posted: Mar 22, 2018
Start date: Sep 6, 2017
Primary completion: Dec 3, 2018
Completion: Dec 3, 2018
Results posted: Feb 17, 2020
Last update: Jun 9, 2020

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Seralutinib

Other studies from this sponsor

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

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