Trial Outcomes & Findings for A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults (NCT NCT04661839)
NCT ID: NCT04661839
Last Updated: 2025-06-08
Results Overview
Number of subjects with AEs and severity of AEs up to 3 days post-dosing.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Day 1 through Day 4
Results posted on
2025-06-08
Participant Flow
Participant milestones
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
4
|
|
Overall Study
Safety Population
|
8
|
8
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
8
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Overall Study
Not Treated
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
Baseline characteristics by cohort
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 Participants
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 Participants
Eligible subjects will be randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
30.6 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
19 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Height
|
173.0 centimeters
STANDARD_DEVIATION 8.9 • n=5 Participants
|
172.1 centimeters
STANDARD_DEVIATION 12.2 • n=7 Participants
|
168.4 centimeters
STANDARD_DEVIATION 12.3 • n=5 Participants
|
184.8 centimeters
STANDARD_DEVIATION 14.9 • n=4 Participants
|
173.3 centimeters
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Baseline weight
|
72.2 kilograms
STANDARD_DEVIATION 11.9 • n=5 Participants
|
79.3 kilograms
STANDARD_DEVIATION 12.4 • n=7 Participants
|
74.1 kilograms
STANDARD_DEVIATION 15.9 • n=5 Participants
|
80.8 kilograms
STANDARD_DEVIATION 15.7 • n=4 Participants
|
76.1 kilograms
STANDARD_DEVIATION 13.4 • n=21 Participants
|
|
Baseline body mass index
|
24.1 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.7 • n=5 Participants
|
26.9 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.5 • n=7 Participants
|
25.9 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.2 • n=5 Participants
|
23.5 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 1.2 • n=4 Participants
|
25.3 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 3.7 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 4Population: Safety population includes all subjects who received any amount of study treatment.
Number of subjects with AEs and severity of AEs up to 3 days post-dosing.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 Participants
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Subjects With Adverse Events (AEs) up to 3 Days Post-dosing
Subjects with an adverse event (AE)
|
3 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Subjects With Adverse Events (AEs) up to 3 Days Post-dosing
Subjects with a severe adverse event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0 hours to 2.5 hoursPopulation: Safety population includes all subjects who received any amount of study treatment.
Number of subjects and severity of treatment emergent adverse events (TEAEs) that led to discontinuation or temporary suspension of IV infusion.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 Participants
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Subjects With Adverse Events That Led to Discontinuation or Temporary Suspension of IV Infusion
Any TEAE leading to infusion interruption
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Subjects With Adverse Events That Led to Discontinuation or Temporary Suspension of IV Infusion
Any TEAE leading to infusion discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: Safety population includes all subjects who received any amount of study treatment.
Number of subjects with TEAEs and SAEs up to 84 days post-dosing.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 Participants
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Subjects With AEs and SAEs After IV Infusion
Number of subjects with any TEAE
|
3 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Subjects With AEs and SAEs After IV Infusion
Number of subjects with serious adverse events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: Safety population includes all subjects who received any amount of study treatment.
Number of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in all subjects reporting TEAEs/SAEs up to 84 days post-dosing.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 Participants
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Total Number of AEs and SAEs After IV Infusion
Total number of adverse events (AEs) for all subjects reporting TEAEs
|
5 Events
|
18 Events
|
19 Events
|
8 Events
|
|
Total Number of AEs and SAEs After IV Infusion
Total number of SAEs for all subjects reporting SAEs
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIGIV
|
2961.93 h*Alliance Units (AU)/mL
Interval 2246.17 to 3905.77
|
6678.80 h*Alliance Units (AU)/mL
Interval 6014.8 to 7416.11
|
11722.82 h*Alliance Units (AU)/mL
Interval 10108.67 to 13594.72
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
Area under the concentration-time curve from time 0 to the last quantifiable concentration plus the additional area extrapolated to infinity of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV
|
3818.25 h*AU/mL
Interval 2729.49 to 5341.31
|
8255.74 h*AU/mL
Interval 7341.21 to 9284.19
|
13028.08 h*AU/mL
Interval 11014.89 to 15409.22
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 15Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
AUC from time 0 to 14 days (AUC0-14d) of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, and Day 15.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=5 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days After Dose of COVID-HIGIV
|
3398.55 h*AU/mL
Interval 2579.6 to 4477.49
|
6834.66 h*AU/mL
Interval 6142.3 to 7605.06
|
11722.82 h*AU/mL
Interval 10108.67 to 13594.72
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIGIV
|
2961.93 h*AU/mL
Interval 2246.17 to 3905.77
|
6678.80 h*AU/mL
Interval 6014.8 to 7416.11
|
11296.33 h*AU/mL
Interval 9765.56 to 13067.06
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The Cmax of SARS-CoV-2 binding IgG antibodies observed after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIGIV
|
7.69 AU/mL
Interval 6.6 to 8.97
|
17.02 AU/mL
Interval 15.63 to 18.54
|
33.27 AU/mL
Interval 28.69 to 38.58
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
Time at which Cmax occurs (Tmax) after COVID-HIGIV at each dose level .Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIGIV
|
7.09 hours
Standard Deviation 7.84
|
7.93 hours
Standard Deviation 6.81
|
5.36 hours
Standard Deviation 1.46
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIGIV
|
2.06 AU/mL
Interval 1.31 to 3.22
|
3.33 AU/mL
Interval 2.99 to 3.7
|
5.47 AU/mL
Interval 4.56 to 6.56
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The apparent terminal elimination half-life (T1/2) after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Apparent Terminal Elimination Half-life (T1/2) After Dose of COVID-HIGIV
|
583.13 hours
Standard Deviation 237.39
|
752.87 hours
Standard Deviation 257.67
|
618.79 hours
Standard Deviation 148.64
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The systemic clearance (CL) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Systemic Clearance (CL) After Dose of COVID-HIGIV
|
0.0194 mL/h
Interval 0.0138 to 0.0272
|
0.0188 mL/h
Interval 0.0156 to 0.0227
|
0.0223 mL/h
Interval 0.0176 to 0.0284
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The volume of distribution (Vz) of SARS-CoV-2 binding IgG antibodies after dose of COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Pharmacokinetics Parameter of Volume of Distribution (Vz) After Dose of COVID-HIGIV
|
15.19 mL
Interval 11.74 to 19.65
|
19.72 mL
Interval 17.01 to 22.86
|
19.40 mL
Interval 16.2 to 23.23
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The body-weight normalized Cmax (CmaxBWN) of SARS-CoV-2 binding antibodies observed after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Body-weight Normalized Pharmacokinetics Parameter of Maximum Observed Concentration of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIGIV
|
0.11 AU/mL/kg
Interval 0.09 to 0.14
|
0.22 AU/mL/kg
Interval 0.19 to 0.26
|
0.45 AU/mL/kg
Interval 0.39 to 0.53
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The body-weight normalized area under the concentration-time curve from time 0 to the last quantifiable concentration of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIGIV
|
41.83 h*AU/mL/kg
Interval 30.11 to 58.12
|
85.23 h*AU/mL/kg
Interval 71.82 to 101.14
|
161.44 h*AU/mL/kg
Interval 129.11 to 201.87
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 85Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The body-weight normalized area under the concentration-time curve from time 0 to the last quantifiable concentration plus the additional area extrapolated to infinity of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57 and Day 85.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to the Last Quantifiable Concentration of SARS-CoV-2 Antibodies Plus the Additional Area Extrapolated to Infinity (AUC0-inf) After Dose of COVID-HIGIV
|
52.07 h*AU/mL/kg
Interval 36.85 to 73.56
|
105.39 h*AU/mL/kg
Interval 87.53 to 126.89
|
179.39 h*AU/mL/kg
Interval 139.91 to 230.02
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 15Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
Body-weight normalized AUC from time 0 to 14 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, and Day 15.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=5 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 14 Days (AUC0-14d) After Dose of COVID-HIGIV
|
45.90 h*AU/mL/kg
Interval 28.37 to 74.25
|
87.73 h*AU/mL/kg
Interval 72.74 to 105.82
|
161.44 h*AU/mL/kg
Interval 129.11 to 201.87
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
AUC from time 0 to 28 days of SARS-CoV-2 binding IgG antibodies after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Body-weight Normalized Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to 28 Days (AUC0-28d) After Dose of COVID-HIGIV
|
41.83 h*AU/mL/kg
Interval 30.11 to 58.12
|
85.23 h*AU/mL/kg
Interval 71.82 to 101.14
|
161.17 h*AU/mL/kg
Interval 122.08 to 212.77
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The PK population included all subjects who received COVID-HIGIV and had an adequate set of evaluable PK samples (a suitable predose sample and at least one measurable postdose sample).
The body-weight normalized observed trough concentration of SARS-CoV-2 binding IgG antibodies 28 days after COVID-HIGIV dose. Data for PK calculations was collected: pre-dose within 2 hrs prior to dosing, and post-dose at: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, Day 4, Day 8, Day 15, Day 22, and Day 29.
Outcome measures
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=7 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=6 Participants
Eligible subjects randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
Eligible subjects randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Body-weight Normalized Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIGIV
|
0.0291 AU/mL/kg
Interval 0.0172 to 0.0494
|
0.0425 AU/mL/kg
Interval 0.0371 to 0.0487
|
0.0780 AU/mL/kg
Interval 0.0568 to 0.1072
|
—
|
Adverse Events
COVID-HIGIV Dose Level 1 (100 mg/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
COVID-HIGIV Dose Level 2 (200 mg/kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
COVID-HIGIV Dose Level 3 (400 mg/kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Placebo (Saline)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
Other adverse events
| Measure |
COVID-HIGIV Dose Level 1 (100 mg/kg)
n=8 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 1 (100 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 2 (200 mg/kg)
n=8 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 2 (200 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
COVID-HIGIV Dose Level 3 (400 mg/kg)
n=7 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of COVID-HIGIV dose level 3 (400 mg/kg).
COVID-HIGIV: COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
|
Dose Placebo (Saline)
n=4 participants at risk
Eligible subjects will be randomized to receive a single IV infusion of saline placebo.
Placebo (saline): The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
General disorders
Infusion site pain
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
General disorders
Xerosis
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
71.4%
5/7 • Number of events 6 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
|
Vascular disorders
Thrombophlebitis superficial
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/8 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/7 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
0.00%
0/4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal.
Adverse events were unsolicited.
|
Additional Information
Clinical Development Representative
Emergent BioSolutions Canada Inc.
Phone: 204-275-4074
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER