Trial Outcomes & Findings for A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects (NCT NCT03809052)

NCT ID: NCT03809052

Last Updated: 2021-03-17

Results Overview

The number of participants in each arm that report Adverse Events (AEs)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

78 participants

Primary outcome timeframe

Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks

Results posted on

2021-03-17

Participant Flow

A total of 78 subjects entered the study and were randomised to treatment, with 56 subjects in Part A and 22 subjects in Part B.

Participant milestones

Participant milestones
Measure	A1 - 5 mg GB1211 Single Dose 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A2 - 20 mg GB1211 Single Dose 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A3 - 50 mg GB1211 Single Dose (Food Effect Cohort) 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods. GB1211: Hard capsules for oral use	A4 - 100 mg GB1211 Single Dose 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A5 - 200 mg GB1211 Single Dose 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A6 - 50mg GB1211 Single Dose 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use	A7 - 400 mg GB1211 Single Dose 6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use	Part A - Placebo GB1211 In Part A, 14 subjects will receive placebo in total. Placebo: Hard capsules for oral use	B1 - GB1211 Multiple Ascending Doses, 50mg BID GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use	B2 - GB1211 Multiple Ascending Doses, 100mg BID GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use	Part B - PLacebo GB1211 (BID) In Part B, 6 subjects will receive placebo in total. Placebo: Hard capsules for oral use
Overall Study STARTED	6	6	6	6	6	6	6	14	8	8	6
Overall Study COMPLETED	6	6	6	6	6	6	6	14	8	8	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A1 - 5 mg GB1211 Single Dose n=6 Participants 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A2 - 20 mg GB1211 Single Dose n=6 Participants 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A3 - 50 mg GB1211 Single Dose (Food Effect Cohort) n=6 Participants 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A4 - 100 mg GB1211 Single Dose n=6 Participants 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A5 - 200 mg GB1211 Single Dose n=6 Participants 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use	A6 - 50mg GB1211 Single Dose n=6 Participants 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use	A7 - 400 mg GB1211 Single Dose n=6 Participants 6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use	Part A - Placebo for GB1211 n=14 Participants In Part A, 14 subjects will receive placebo in total. Placebo: Hard capsules for oral use Placebo: Hard capsules for oral use	B1 - GB1211 Multiple Ascending Doses, 50mg BID n=8 Participants GB1211 50mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use	B2 - GB1211 Multiple Ascending Doses, 100mg BID n=8 Participants GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use	Part B - Placebo for GB1211 (BID) n=6 Participants In Part B, 6 subjects will receive placebo in total. Placebo: Hard capsules for oral use Placebo: Hard capsules for oral use	Total n=78 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 7.4 • n=99 Participants	38 years STANDARD_DEVIATION 12.8 • n=107 Participants	28 years STANDARD_DEVIATION 8.0 • n=206 Participants	35 years STANDARD_DEVIATION 9.2 • n=7 Participants	36 years STANDARD_DEVIATION 12.8 • n=31 Participants	34 years STANDARD_DEVIATION 13.5 • n=30 Participants	39 years STANDARD_DEVIATION 11.3 • n=3 Participants	37 years STANDARD_DEVIATION 13.3 • n=6 Participants	42 years STANDARD_DEVIATION 12.6 • n=114 Participants	37 years STANDARD_DEVIATION 11.6	39 years STANDARD_DEVIATION 8.1 • n=19 Participants	36 years STANDARD_DEVIATION 11.0 • n=4 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants	2 Participants n=30 Participants	2 Participants n=3 Participants	6 Participants n=6 Participants	3 Participants n=114 Participants	3 Participants	2 Participants n=19 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	5 Participants n=7 Participants	5 Participants n=31 Participants	4 Participants n=30 Participants	4 Participants n=3 Participants	8 Participants n=6 Participants	5 Participants n=114 Participants	5 Participants	4 Participants n=19 Participants	51 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	6 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	6 Participants n=3 Participants	14 Participants n=6 Participants	8 Participants n=114 Participants	8 Participants	6 Participants n=19 Participants	78 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=3 Participants	3 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	5 Participants n=30 Participants	6 Participants n=3 Participants	11 Participants n=6 Participants	8 Participants n=114 Participants	8 Participants	6 Participants n=19 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants
Weight	75.9 kilogram STANDARD_DEVIATION 7.27 • n=99 Participants	77.9 kilogram STANDARD_DEVIATION 19.03 • n=107 Participants	71.4 kilogram STANDARD_DEVIATION 7.87 • n=206 Participants	75.1 kilogram STANDARD_DEVIATION 13.94 • n=7 Participants	73.7 kilogram STANDARD_DEVIATION 11.61 • n=31 Participants	73.3 kilogram STANDARD_DEVIATION 16.72 • n=30 Participants	79.7 kilogram STANDARD_DEVIATION 12.63 • n=3 Participants	81.3 kilogram STANDARD_DEVIATION 12.82 • n=6 Participants	85.4 kilogram STANDARD_DEVIATION 17.20 • n=114 Participants	76.8 kilogram STANDARD_DEVIATION 9.52	70.9 kilogram STANDARD_DEVIATION 13.24 • n=19 Participants	76.5 kilogram STANDARD_DEVIATION 12.9 • n=4 Participants
Height	172.3 centimeter STANDARD_DEVIATION 10.31 • n=99 Participants	171.7 centimeter STANDARD_DEVIATION 9.65 • n=107 Participants	169.8 centimeter STANDARD_DEVIATION 5.00 • n=206 Participants	175.3 centimeter STANDARD_DEVIATION 5.20 • n=7 Participants	174.7 centimeter STANDARD_DEVIATION 8.45 • n=31 Participants	176.2 centimeter STANDARD_DEVIATION 12.86 • n=30 Participants	173.7 centimeter STANDARD_DEVIATION 8.12 • n=3 Participants	173.6 centimeter STANDARD_DEVIATION 10.26 • n=6 Participants	178.9 centimeter STANDARD_DEVIATION 7.62 • n=114 Participants	173.4 centimeter STANDARD_DEVIATION 4.21	175.2 centimeter STANDARD_DEVIATION 5.71 • n=19 Participants	174.1 centimeter STANDARD_DEVIATION 7.9 • n=4 Participants
BMI	25.9 kg/m^2 STANDARD_DEVIATION 4.48 • n=99 Participants	26.1 kg/m^2 STANDARD_DEVIATION 3.91 • n=107 Participants	24.8 kg/m^2 STANDARD_DEVIATION 2.73 • n=206 Participants	24.5 kg/m^2 STANDARD_DEVIATION 4.63 • n=7 Participants	24.1 kg/m^2 STANDARD_DEVIATION 3.25 • n=31 Participants	23.3 kg/m^2 STANDARD_DEVIATION 2.86 • n=30 Participants	26.2 kg/m^2 STANDARD_DEVIATION 1.90 • n=3 Participants	26.9 kg/m^2 STANDARD_DEVIATION 3.06 • n=6 Participants	26.5 kg/m^2 STANDARD_DEVIATION 3.78 • n=114 Participants	25.5 kg/m^2 STANDARD_DEVIATION 2.35	23.0 kg/m^2 STANDARD_DEVIATION 3.50 • n=19 Participants	25.2 kg/m^2 STANDARD_DEVIATION 3.3 • n=4 Participants

PRIMARY outcome

Timeframe: Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks

Population: All subjects in part A and B were included in the safety populations. The safety population will include all subjects who received at least 1 dose of study treatment (GB1211 or placebo). Safety parameters will be listed and summarised using descriptive statistics. No formal statistical analysis of safety data is planned.

The number of participants in each arm that report Adverse Events (AEs)