Trial Outcomes & Findings for A Study to Evaluate Plasma Gelsolin in Healthy Volunteers (NCT NCT05789745)

NCT ID: NCT05789745

Last Updated: 2024-09-19

Results Overview

Number of subjects who had an Adverse Event

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

28 days

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (6 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Overall Study STARTED	6	6	6	6	8
Overall Study COMPLETED	6	6	6	6	7
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (6 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Overall Study Withdrawal by Subject	0	0	0	0	1

Baseline Characteristics

A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (6 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 n=8 Participants Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.	Total n=32 Participants Total of all reporting groups
Age, Continuous	34.0 years n=5 Participants	41.5 years n=7 Participants	36.0 years n=5 Participants	37.5 years n=4 Participants	28.5 years n=21 Participants	36.5 years n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	12 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	20 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	27 Participants n=8 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
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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	24 Participants n=8 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
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
BMI	24.50 kg/m^2 n=5 Participants	24.65 kg/m^2 n=7 Participants	26.60 kg/m^2 n=5 Participants	25.95 kg/m^2 n=4 Participants	23.85 kg/m^2 n=21 Participants	24.75 kg/m^2 n=8 Participants

PRIMARY outcome

Timeframe: 28 days

Number of subjects who had an Adverse Event

Outcome measures

Outcome measures
Measure	Cohort 1 (6 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 n=8 Participants Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Adverse Events	1 Participants	2 Participants	3 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 28 days

Number of subjects who had a Serious Adverse Event

Outcome measures

Outcome measures
Measure	Cohort 1 (6 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 n=8 Participants Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 108 hours

Concentration of pGSN at baseline, 12 hours after dose 1, and 24 hours after doses 2 and 5

Outcome measures

Outcome measures
Measure	Cohort 1 (6 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) n=5 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Pharmacokinetics: pGSN Concentration Cmax (Dose 2)	225.2 micrograms/mL Standard Deviation 27.0	506.9 micrograms/mL Standard Deviation 78.5	691.5 micrograms/mL Standard Deviation 110.5	855.7 micrograms/mL Standard Deviation 200.6	—
Pharmacokinetics: pGSN Concentration Cmax (Dose 5)	218.9 micrograms/mL Standard Deviation 37.7	501.6 micrograms/mL Standard Deviation 60.4	703.8 micrograms/mL Standard Deviation 140.7	970.9 micrograms/mL Standard Deviation 87.9	—
Pharmacokinetics: pGSN Concentration Baseline	63.6 micrograms/mL Standard Deviation 13.2	61.2 micrograms/mL Standard Deviation 19.7	59.1 micrograms/mL Standard Deviation 8.8	71.8 micrograms/mL Standard Deviation 11.1	—
Pharmacokinetics: pGSN Concentration Cmax (Dose 1)	148.4 micrograms/mL Standard Deviation 26.8	347.5 micrograms/mL Standard Deviation 41.2	442.5 micrograms/mL Standard Deviation 50.2	663.6 micrograms/mL Standard Deviation 110.8	—

SECONDARY outcome

Timeframe: 108 hours

Area Under the Curve (AUC) of pGSN concentration at 12 hours after dose 1, and 24 hours after doses 2 and 5

Outcome measures

Outcome measures
Measure	Cohort 1 (6 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) n=5 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Pharmacokinetics: pGSN Area Under the Curve (AUC) AUC0-12 (dose 1)	1245.5 hours*(micrograms/mL) Standard Deviation 257.9	2737.5 hours*(micrograms/mL) Standard Deviation 379.1	3547.0 hours*(micrograms/mL) Standard Deviation 657.3	4832.3 hours*(micrograms/mL) Standard Deviation 646.6	—
Pharmacokinetics: pGSN Area Under the Curve (AUC) AUC0-24 (dose 2)	3066.2 hours*(micrograms/mL) Standard Deviation 256.8	6448.5 hours*(micrograms/mL) Standard Deviation 599.5	9374.2 hours*(micrograms/mL) Standard Deviation 2456.0	10258.2 hours*(micrograms/mL) Standard Deviation 2035.6	—
Pharmacokinetics: pGSN Area Under the Curve (AUC) AUC0-24 (dose 5)	3486.5 hours*(micrograms/mL) Standard Deviation 1035.2	6599.1 hours*(micrograms/mL) Standard Deviation 1334.2	9139.1 hours*(micrograms/mL) Standard Deviation 793.1	12135.3 hours*(micrograms/mL) Standard Deviation 1172.4	—

SECONDARY outcome

Timeframe: 108 hours

Half-life of pGSN concentration 12 hours after dose 1, and 24 hours after doses 2 and 5

Outcome measures

Outcome measures
Measure	Cohort 1 (6 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 2 (12 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 3 (18 mg/kg) n=5 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Cohort 4 (24 mg/kg) n=6 Participants IV rhu-pGSN administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4)	Placebo Cohorts 1-4 Dosed at a weight-based volume of 0.025 mL/mg × dose in mg/kg × weight in kg of 0.9% saline solution via IV push (matching the volume of rhu-pGSN for a subject of that size) injected at ≤20 mL/minute though a standard 0.2 μ filter. Placebo was administered on the same schedule as the active drug.
Pharmacokinetics: pGSN Half-life t1/2 (dose 1)	14.0 hours Standard Deviation 5.4	13.1 hours Standard Deviation 2.6	9.2 hours Standard Deviation 3.0	10.7 hours Standard Deviation 5.2	—
Pharmacokinetics: pGSN Half-life t1/2 (dose 2)	16.7 hours Standard Deviation 6.1	14.5 hours Standard Deviation 3.4	15.1 hours Standard Deviation 4.5	12.0 hours Standard Deviation 1.5	—
Pharmacokinetics: pGSN Half-life t1/2 (dose 5)	28.4 hours Standard Deviation 8.5	22.0 hours Standard Deviation 11.3	17.6 hours Standard Deviation 1.9	14.5 hours Standard Deviation 2.2	—

SECONDARY outcome

Timeframe: 28 days

Number of participants who tested positive for anti-pGSN antibodies at baseline, and on day 28