Trial Outcomes & Findings for Phase 1A Safety Trial of Inhaled PK10571 (GB002) (NCT NCT03473236)
NCT ID: NCT03473236
Last Updated: 2020-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 days
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
SAD PK10571 (GB002) Placebo QD
A placebo single ascending dose (SAD) inhaled once a day (QD) over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo multiple ascending dose (MAD) inhaled either twice daily (BID) or thrice daily (TID) over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
6
|
7
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
SAD PK10571 (GB002) Placebo QD
A placebo single ascending dose (SAD) inhaled once a day (QD) over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo multiple ascending dose (MAD) inhaled either twice daily (BID) or thrice daily (TID) over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
Baseline characteristics by cohort
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 7.54 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 8.78 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 6.28 • n=21 Participants
|
35.4 years
STANDARD_DEVIATION 9.59 • n=8 Participants
|
33.3 years
STANDARD_DEVIATION 11.31 • n=8 Participants
|
49.3 years
STANDARD_DEVIATION 4.13 • n=24 Participants
|
31.7 years
STANDARD_DEVIATION 8.83 • n=42 Participants
|
41.0 years
STANDARD_DEVIATION 6.10 • n=42 Participants
|
38.8 years
STANDARD_DEVIATION 9.06 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
|
Height
|
172.52 cm
STANDARD_DEVIATION 12.156 • n=5 Participants
|
165.82 cm
STANDARD_DEVIATION 10.699 • n=7 Participants
|
171.03 cm
STANDARD_DEVIATION 14.785 • n=5 Participants
|
169.30 cm
STANDARD_DEVIATION 6.427 • n=4 Participants
|
172.58 cm
STANDARD_DEVIATION 16.351 • n=21 Participants
|
165.84 cm
STANDARD_DEVIATION 11.783 • n=8 Participants
|
169.22 cm
STANDARD_DEVIATION 11.468 • n=8 Participants
|
162.27 cm
STANDARD_DEVIATION 8.190 • n=24 Participants
|
164.43 cm
STANDARD_DEVIATION 9.351 • n=42 Participants
|
167.45 cm
STANDARD_DEVIATION 10.418 • n=42 Participants
|
168.23 cm
STANDARD_DEVIATION 11.220 • n=42 Participants
|
|
Bodyweight
|
79.55 kg
STANDARD_DEVIATION 8.023 • n=5 Participants
|
77.77 kg
STANDARD_DEVIATION 15.075 • n=7 Participants
|
70.37 kg
STANDARD_DEVIATION 16.170 • n=5 Participants
|
76.33 kg
STANDARD_DEVIATION 8.091 • n=4 Participants
|
90.68 kg
STANDARD_DEVIATION 18.925 • n=21 Participants
|
70.37 kg
STANDARD_DEVIATION 6.307 • n=8 Participants
|
81.27 kg
STANDARD_DEVIATION 15.944 • n=8 Participants
|
74.58 kg
STANDARD_DEVIATION 12.449 • n=24 Participants
|
72.24 kg
STANDARD_DEVIATION 8.247 • n=42 Participants
|
65.45 kg
STANDARD_DEVIATION 12.565 • n=42 Participants
|
75.95 kg
STANDARD_DEVIATION 13.255 • n=42 Participants
|
|
BMI
|
26.85 kg/m^2
STANDARD_DEVIATION 2.804 • n=5 Participants
|
28.07 kg/m^2
STANDARD_DEVIATION 3.195 • n=7 Participants
|
23.88 kg/m^2
STANDARD_DEVIATION 3.407 • n=5 Participants
|
26.60 kg/m^2
STANDARD_DEVIATION 1.932 • n=4 Participants
|
30.18 kg/m^2
STANDARD_DEVIATION 1.520 • n=21 Participants
|
25.86 kg/m^2
STANDARD_DEVIATION 3.574 • n=8 Participants
|
28.25 kg/m^2
STANDARD_DEVIATION 3.384 • n=8 Participants
|
28.18 kg/m^2
STANDARD_DEVIATION 2.712 • n=24 Participants
|
26.89 kg/m^2
STANDARD_DEVIATION 3.609 • n=42 Participants
|
23.20 kg/m^2
STANDARD_DEVIATION 2.589 • n=42 Participants
|
26.79 kg/m^2
STANDARD_DEVIATION 3.352 • n=42 Participants
|
PRIMARY outcome
Timeframe: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 daysPopulation: Safety Population: all participants who received any study drug.
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.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious Treatment Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE Leading to Early Termination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 daysPopulation: Safety Population: all participants who received any study drug.
Vital signs evaluated included blood pressure, pulse oximetry, respiratory rate, and temperature.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Findings Reported as TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 daysPopulation: Safety Population: all participants who received any study drug.
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.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: SAD: Baseline, Day 2, 24 hours; MAD: Baseline, Day 8, 24 hoursPopulation: Safety Population: all participants who received any study drug.
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.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in ECG Data (Overall Interpretation)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: SAD: from first dose of study drug to 11 days, MAD: from first dose of study drug to 35 daysPopulation: Safety Population: all participants who received any study drug.
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.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=5 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Findings in Pulmonary Function Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Analysis of Inhaled GB002: Maximum Concentration (Cmax), SAD
|
19.4 ng/mL
Geometric Coefficient of Variation 41.32
|
51.7 ng/mL
Geometric Coefficient of Variation 36.88
|
161 ng/mL
Geometric Coefficient of Variation 33.12
|
184 ng/mL
Geometric Coefficient of Variation 78.39
|
377 ng/mL
Geometric Coefficient of Variation 32.94
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Time to Cmax (Tmax), SAD
|
0.0833 hours
Interval 0.0833 to 0.0833
|
0.0500 hours
Interval 0.05 to 0.183
|
0.0500 hours
Interval 0.05 to 0.05
|
0.0500 hours
Interval 0.05 to 0.05
|
0.0833 hours
Interval 0.0833 to 0.0833
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUClast), SAD
|
28.7 h*ng/mL
Geometric Coefficient of Variation 35.19
|
60.6 h*ng/mL
Geometric Coefficient of Variation 23.01
|
147 h*ng/mL
Geometric Coefficient of Variation 19.51
|
214 h*ng/mL
Geometric Coefficient of Variation 28.55
|
423 h*ng/mL
Geometric Coefficient of Variation 44.51
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Area Under the Curve From Time 0 Hours to Infinity (AUCinf), SAD
|
28.9 h*ng/mL
Geometric Coefficient of Variation 34.50
|
60.9 h*ng/mL
Geometric Coefficient of Variation 22.90
|
147 h*ng/mL
Geometric Coefficient of Variation 19.43
|
215 h*ng/mL
Geometric Coefficient of Variation 28.48
|
423 h*ng/mL
Geometric Coefficient of Variation 44.41
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Apparent Terminal Elimination Half-Life (t1/2), SAD
|
3.48 hours
Geometric Coefficient of Variation 25.72
|
3.08 hours
Geometric Coefficient of Variation 28.54
|
3.32 hours
Geometric Coefficient of Variation 12.68
|
4.41 hours
Geometric Coefficient of Variation 23.00
|
4.16 hours
Geometric Coefficient of Variation 20.35
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
CL/F is based on nominal (scheduled) dose.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance (CL/F), SAD
|
130 L/h
Geometric Coefficient of Variation 34.50
|
123 L/h
Geometric Coefficient of Variation 22.90
|
102 L/h
Geometric Coefficient of Variation 19.43
|
140 L/h
Geometric Coefficient of Variation 28.48
|
113 L/h
Geometric Coefficient of Variation 44.41
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Vz/F is based on nominal (scheduled) dose.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Apparent Volume of Distribution (Vz/F), SAD
|
650 L
Geometric Coefficient of Variation 25.86
|
548 L
Geometric Coefficient of Variation 24.12
|
489 L
Geometric Coefficient of Variation 18.33
|
889 L
Geometric Coefficient of Variation 32.24
|
681 L
Geometric Coefficient of Variation 44.68
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=7 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Cmax After Dose 1, MAD
Day 1
|
146 ng/ml
Geometric Coefficient of Variation 35.4
|
229 ng/ml
Geometric Coefficient of Variation 55.1
|
571 ng/ml
Geometric Coefficient of Variation 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Analysis of Inhaled GB002: Cmax After Dose 1, MAD
Day 7
|
193 ng/ml
Geometric Coefficient of Variation 27.0
|
246 ng/ml
Geometric Coefficient of Variation 49.0
|
528 ng/ml
Geometric Coefficient of Variation 61.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=7 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Tmax After Dose 1, MAD
Day 1
|
0.0833 hours
Interval 0.0833 to 0.0833
|
0.0833 hours
Interval 0.0833 to 0.117
|
0.0833 hours
Interval 0.0833 to 0.0833
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Analysis of Inhaled GB002: Tmax After Dose 1, MAD
Day 7
|
0.0833 hours
Interval 0.0833 to 0.0833
|
0.0833 hours
Interval 0.0833 to 0.0833
|
0.0833 hours
Interval 0.0833 to 0.0833
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=7 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Area Under the Curve From Time Zero to 24 Hours Postdose (AUC0-24), MAD
Day 1
|
355 h*ng/mL
Geometric Coefficient of Variation 25.9
|
870 h*ng/mL
Geometric Coefficient of Variation 38.1
|
1690 h*ng/mL
Geometric Coefficient of Variation 39.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Analysis of Inhaled GB002: Area Under the Curve From Time Zero to 24 Hours Postdose (AUC0-24), MAD
Day 7
|
462 h*ng/mL
Geometric Coefficient of Variation 13.6
|
827 h*ng/mL
Geometric Coefficient of Variation 20.2
|
1870 h*ng/mL
Geometric Coefficient of Variation 42.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=7 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Trough Plasma Concentration (Ctrough), MAD
Day 1
|
1.27 h*ng/mL
Geometric Coefficient of Variation 65.4
|
2.60 h*ng/mL
Geometric Coefficient of Variation 55.3
|
3.83 h*ng/mL
Geometric Coefficient of Variation 30.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Analysis of Inhaled GB002: Trough Plasma Concentration (Ctrough), MAD
Day 7
|
2.11 h*ng/mL
Geometric Coefficient of Variation 51.9
|
2.54 h*ng/mL
Geometric Coefficient of Variation 26.0
|
4.29 h*ng/mL
Geometric Coefficient of Variation 24.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Accumulation Ratio (Rac) for Cmax After Dose 1, MAD
|
1.32 ratio
Geometric Coefficient of Variation 27.3
|
1.13 ratio
Geometric Coefficient of Variation 24.9
|
0.925 ratio
Geometric Coefficient of Variation 39.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Rac for AUC0-24, MAD
|
1.30 ratio
Geometric Coefficient of Variation 25.6
|
0.985 ratio
Geometric Coefficient of Variation 23.5
|
1.11 ratio
Geometric Coefficient of Variation 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Rac for Ctrough, MAD
|
1.66 ratio
Geometric Coefficient of Variation 27.1
|
0.844 ratio
Geometric Coefficient of Variation 41.0
|
1.12 ratio
Geometric Coefficient of Variation 19.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=6 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=5 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: t1/2, MAD
|
4.41 hours
Geometric Coefficient of Variation 7.04
|
4.68 hours
Geometric Coefficient of Variation 18.2
|
5.75 hours
Geometric Coefficient of Variation 22.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=7 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=7 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=7 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Apparent Total Plasma Clearance at Steady-State (CLss/F), MAD
|
77.9 L/h
Geometric Coefficient of Variation 13.55
|
87.1 L/h
Geometric Coefficient of Variation 20.17
|
76.9 L/h
Geometric Coefficient of Variation 42.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK population: all participants who received active study drug and had at least one quantifiable postdose concentration.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=7 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=7 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=7 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Analysis of Inhaled GB002: Vz/F, MAD
|
495 L
Geometric Coefficient of Variation 9.46
|
588 L
Geometric Coefficient of Variation 18.55
|
604 L
Geometric Coefficient of Variation 29.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: SAD: from baseline to 11 days, MAD: from baseline to 35 daysMeasurement of white blood cell count
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=6 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in White Blood Cell Count
|
0.42 10^9 cells/L
Standard Deviation 1.212
|
-0.07 10^9 cells/L
Standard Deviation 1.417
|
-0.25 10^9 cells/L
Standard Deviation 1.334
|
-0.93 10^9 cells/L
Standard Deviation 1.694
|
-0.75 10^9 cells/L
Standard Deviation 1.294
|
-0.16 10^9 cells/L
Standard Deviation 0.875
|
-0.28 10^9 cells/L
Standard Deviation 0.768
|
0.27 10^9 cells/L
Standard Deviation 0.922
|
0.65 10^9 cells/L
Standard Deviation 1.176
|
-0.05 10^9 cells/L
Standard Deviation 0.689
|
OTHER_PRE_SPECIFIED outcome
Timeframe: SAD: from baseline to 11 days, MAD: from baseline to 35 daysMeasurement of hemoglobin
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=6 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin
|
0.08 g/dL
Standard Deviation 0.573
|
-0.62 g/dL
Standard Deviation 0.631
|
-0.50 g/dL
Standard Deviation 0.447
|
-0.30 g/dL
Standard Deviation 0.721
|
0.00 g/dL
Standard Deviation 0.410
|
-0.53 g/dL
Standard Deviation 0.599
|
-0.27 g/dL
Standard Deviation 0.683
|
-1.13 g/dL
Standard Deviation 0.723
|
-1.13 g/dL
Standard Deviation 0.314
|
-0.48 g/dL
Standard Deviation 0.512
|
OTHER_PRE_SPECIFIED outcome
Timeframe: SAD: from baseline to 11 days, MAD: from baseline to 35 daysMeasurement of blood urea nitrogen (BUN) and creatinine.
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=6 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Kidney Function Parameters
Change of Urea Nitrogen (BUN) Concentration
|
-1.50 mg/dL
Standard Deviation 3.689
|
-0.17 mg/dL
Standard Deviation 2.787
|
0.83 mg/dL
Standard Deviation 2.994
|
-0.17 mg/dL
Standard Deviation 2.994
|
-0.33 mg/dL
Standard Deviation 5.317
|
2.29 mg/dL
Standard Deviation 2.289
|
0.00 mg/dL
Standard Deviation 4.050
|
0.83 mg/dL
Standard Deviation 1.722
|
-1.67 mg/dL
Standard Deviation 1.966
|
-0.33 mg/dL
Standard Deviation 3.724
|
|
Change From Baseline in Kidney Function Parameters
Change of Creatinine Concentration
|
-0.01 mg/dL
Standard Deviation 0.099
|
0.03 mg/dL
Standard Deviation 0.052
|
0.02 mg/dL
Standard Deviation 0.075
|
0.00 mg/dL
Standard Deviation 0.089
|
0.03 mg/dL
Standard Deviation 0.151
|
-0.01 mg/dL
Standard Deviation 0.069
|
-0.03 mg/dL
Standard Deviation 0.052
|
-0.07 mg/dL
Standard Deviation 0.082
|
0.10 mg/dL
Standard Deviation 0.253
|
-0.02 mg/dL
Standard Deviation 0.041
|
OTHER_PRE_SPECIFIED outcome
Timeframe: SAD: from baseline to 11 days, MAD: from baseline to 35 daysMeasurement of liver function (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]).
Outcome measures
| Measure |
SAD GB002 Placebo QD
n=10 Participants
A placebo SAD inhaled QD over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 Participants
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 Participants
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 Participants
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 Participants
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 Participants
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 Participants
A placebo MAD inhaled either BID or TID to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 Participants
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=6 Participants
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 Participants
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Liver Function Parameters
AST
|
0.40 U/L
Standard Deviation 3.098
|
-1.17 U/L
Standard Deviation 5.269
|
2.50 U/L
Standard Deviation 2.811
|
1.17 U/L
Standard Deviation 4.750
|
0.17 U/L
Standard Deviation 2.401
|
-1.29 U/L
Standard Deviation 2.563
|
-1.17 U/L
Standard Deviation 3.125
|
-0.67 U/L
Standard Deviation 3.077
|
1.17 U/L
Standard Deviation 7.782
|
-4.17 U/L
Standard Deviation 3.430
|
|
Change From Baseline in Liver Function Parameters
ALT
|
-0.10 U/L
Standard Deviation 7.203
|
-0.50 U/L
Standard Deviation 6.025
|
1.17 U/L
Standard Deviation 1.472
|
-0.17 U/L
Standard Deviation 2.563
|
0.67 U/L
Standard Deviation 3.204
|
-1.14 U/L
Standard Deviation 4.634
|
-2.83 U/L
Standard Deviation 7.653
|
-0.50 U/L
Standard Deviation 3.886
|
3.50 U/L
Standard Deviation 13.096
|
-2.17 U/L
Standard Deviation 4.997
|
Adverse Events
SAD GB002 Placebo QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD GB002 3.75 mg QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD GB002 7.5 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD GB002 15 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD GB002 30 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD GB002 48 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD GB002 Placebo BID/TID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MAD GB002 18 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD GB002 24 mg TID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MAD GB002 48 mg TID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD GB002 Placebo QD
n=10 participants at risk
A placebo single ascending dose (SAD) inhaled once a day (QD) over 11 days in healthy volunteers
|
SAD GB002 3.75 mg QD
n=6 participants at risk
GB002 SAD 3.75 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 7.5 mg QD
n=6 participants at risk
GB002 SAD 7.5 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 15 mg QD
n=6 participants at risk
GB002 SAD 15 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 30 mg QD
n=6 participants at risk
GB002 SAD 30 mg inhaled QD over 11 days in healthy volunteers
|
SAD GB002 48 mg QD
n=7 participants at risk
GB002 SAD 48 mg inhaled QD over 11 days in healthy volunteers
|
MAD GB002 Placebo BID/TID
n=6 participants at risk
A placebo multiple ascending dose (MAD) inhaled either twice daily (BID) or thrice daily (TID) to match the dosing in the MAD arms over 35 days in healthy volunteers
|
MAD GB002 18 mg BID
n=6 participants at risk
GB002 MAD 18 mg inhaled BID over 35 days in healthy volunteers
|
MAD GB002 24 mg TID
n=7 participants at risk
GB002 MAD 24 mg inhaled TID over 35 days in healthy volunteers
|
MAD GB002 48 mg TID
n=6 participants at risk
GB002 MAD 48 mg inhaled TID over 35 days in healthy volunteers
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
General disorders
Application site erythema
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
50.0%
3/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
16.7%
1/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
14.3%
1/7 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
0.00%
0/6 • SAD: from baseline to day 11, MAD: from baseline to day 35
|
Additional Information
R. Aranda M.D. / Senior Vice President of Clinical Development
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Phone: (858) 684-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place