Safety IssuesPhase 1NCT03473236
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
A Phase 1 study testing GB002 and Generic Dry Powder Inhaler in people with Safety Issues, run by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- GB002 and Generic Dry Powder Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 3 Dec 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females (if unable to become pregnant)
- Age 18-55
- Body mass index (BMI) 18-32 kg/m^2 and minimum weight of 50 kg (110 lbs)
- Non-smoker
- Ability to give informed consent
- 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.)
Who cannot join
- Hospitalization within the 6 months prior to the first dose of study treatment
- History or presence of clinically significant 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, chronic obstructive pulmonary disease [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 QT syndrome)
- History or presence of cancer (with the exception of basal cell skin cancer that has been effectively treated)
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- 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 hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (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 forced expiratory volume in 1 second (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 autoimmune 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 ECG (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 [TIA])
- 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 upper limit of normal (ULN) for AST, ALT, or total bilirubin
- Out of range results on the following coagulation tests: INR, 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 creatinine clearance less than 60 mL/min
- Hemoglobin 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1A Single Ascending Dose and Multiple Ascending Dose Double-Blind, Placebo-Controlled, Randomized Trial of Oral Inhalation PK10571 in Healthy Adult Subjects
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
- Safety Issues
- Being tested
- GB002, Generic Dry Powder Inhaler, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB002Drug
Also called PK10571
Inhaled GB002
Generic Dry Powder InhalerDevice
dry powder inhaler used for inhalation of active drug or placebo
PlaceboDrug
Inhaled placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | Dose 1 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 2A | Experimental | Dose 2 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 3A | Experimental | Dose 3 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 4A | Experimental | Dose 4 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 5A | Experimental | Dose 5 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 1B | Experimental | Dose 1 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 2B | Experimental | Dose 2 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
| Cohort 3B | Experimental | Dose 3 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. Receives: Drug: GB002; Device: Generic Dry Powder Inhaler; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start6 Sep 2017
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pulmokine Inc., Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473236
- Sponsor's protocol ID
- 4004002
- Status last verified
- May 2020
- First submitted
- 8 Mar 2018
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1A Single Ascending Dose and Multiple Ascending Dose Double-Blind, Placebo-Controlled, Randomized Trial of Oral Inhalation PK10571 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03473236
- Acronym / sponsor ID
- 4004002
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pulmokine Inc., Worldwide Clinical Trials
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 1 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 2A | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 2 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 3A | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 3 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 4A | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 4 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 5A | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 5 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 1B | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 1 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 2B | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 2 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 3B | Experimental | Drug: GB002, Device: Generic Dry Powder Inhaler, Drug: PlaceboDose 3 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females (if unable to become pregnant)
- Age 18-55
- Body mass index (BMI) 18-32 kg/m^2 and minimum weight of 50 kg (110 lbs)
- Non-smoker
- Ability to give informed consent
Key exclusion criteria (53 listed)
- Hospitalization within the 6 months prior to the first dose of study treatment
- History or presence of clinically significant 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, chronic obstructive pulmonary disease [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 QT syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB002Also: PK10571Inhaled GB002 | Drug | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 3B, Cohort 4A, Cohort 5A |
| Generic Dry Powder Inhalerdry powder inhaler used for inhalation of active drug or placebo | Device | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 3B, Cohort 4A, Cohort 5A |
| PlaceboInhaled placebo | Drug | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 3B, Cohort 4A, Cohort 5A |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
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.
Number of Participants With Vital Sign Findings Reported as TEAEs
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Vital signs evaluated included blood pressure, pulse oximetry, respiratory rate, and temperature.
Number of Participants With Clinically Significant Findings in Physical Examinations
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
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.
Number of Participants With Clinically Significant Changes From Baseline in ECG Data (Overall Interpretation)
Time frame: SAD: Baseline, Day 2, 24 hours; MAD: Baseline, Day 8, 24 hours
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.
Number of Participants With Clinically Significant Abnormal Findings in Pulmonary Function Tests
Time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
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.
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
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
CL/F is based on nominal (scheduled) dose.
PK Analysis of Inhaled GB002: Apparent Volume of Distribution (Vz/F), 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
Vz/F is based on nominal (scheduled) dose.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB002 and Generic Dry Powder Inhaler in people with Safety Issues, run by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.