Trial Outcomes & Findings for 3BNC117-LS First-in-Human Phase 1 Study (NCT NCT03254277)
NCT ID: NCT03254277
Last Updated: 2026-05-20
Results Overview
Adverse events include signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
2 weeks following the 3BNC117-LS infusion
Results posted on
2026-05-20
Participant Flow
Participant milestones
| Measure |
Group 1A
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1B
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1C
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 2B
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 2C
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1D
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 2D
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1E 3BNC117-LS
HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
3BNC117-LS: subcutaneous infection of 3BNC117-LS
|
Group 1F 3BNC117-LS
HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
3BNC117-LS: subcutaneous injection of 3BNC117-LS
|
Group 1E Placebo
HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Placebo: 1mL normal saline
|
Group 1F Placebo
HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Placebo: 2mL normal saline
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
6
|
2
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
3
|
6
|
2
|
3
|
6
|
6
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3BNC117-LS First-in-Human Phase 1 Study
Baseline characteristics by cohort
| Measure |
Group 1C
n=6 Participants
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1A
n=3 Participants
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1B
n=3 Participants
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 2B
n=3 Participants
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 2C
n=6 Participants
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1D
n=3 Participants
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 2D
n=3 Participants
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
3BNC117-LS: Intravenous infusion of 3BNC117-LS
|
Group 1E 3BNC117-LS
n=6 Participants
HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
3BNC117-LS: subcutaneous injection of 3BNC117-LS
|
Group 1F 3BNC117-LS
n=6 Participants
HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
3BNC117-LS: subcutaneous injection of 3BNC117-LS
|
Group 1E Placebo
n=2 Participants
HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Placebo: 1mL normal saline
|
Group 1F Placebo
n=2 Participants
HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Placebo: 1mL normal saline
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=60 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=133 Participants
|
6 Participants
n=6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
2 Participants
n=120 Participants
|
2 Participants
n=40 Participants
|
43 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
39 years
n=60 Participants
|
31 years
n=30 Participants
|
42 years
n=30 Participants
|
48 years
n=133 Participants
|
49 years
n=6 Participants
|
37 years
|
50 years
|
46 years
n=71 Participants
|
44 years
n=40 Participants
|
54 years
n=120 Participants
|
47 years
n=40 Participants
|
49 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
1 Participants
n=6 Participants
|
2 Participants
|
1 Participants
|
3 Participants
n=71 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=120 Participants
|
1 Participants
n=40 Participants
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=60 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=133 Participants
|
5 Participants
n=6 Participants
|
1 Participants
|
2 Participants
|
3 Participants
n=71 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=40 Participants
|
23 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=60 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=133 Participants
|
4 Participants
n=6 Participants
|
3 Participants
|
3 Participants
|
4 Participants
n=71 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=40 Participants
|
27 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=133 Participants
|
2 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
2 Participants
n=71 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=40 Participants
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=60 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=133 Participants
|
6 Participants
n=6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
2 Participants
n=120 Participants
|
2 Participants
n=40 Participants
|
43 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 2 weeks following the 3BNC117-LS infusionPopulation: All participants who received the investigational product
Adverse events include signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity adverse events.
Outcome measures
| Measure |
Group 1C
n=6 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2B
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
Group 2C
n=6 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1D
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2D
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1E - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 150 mg
|
Group 1F - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 300 mg
|
Group 1E -Placebo
n=2 Participants
Participants without HIV, who received a single subcutaneous injection of placebo (1 mL)
|
Group 1F - Placebo
n=2 Participants
Participants without HIV, who received a single subcutaneous injection of placebo (2 mL)
|
Group 1A
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 3 mg/kg.
|
Group 1B
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Groups 1E placebo and 1F placebo were not analyzed as they did not received the investigational product
Elimination half-life (t1/2) measured in days of 3BNC117-LS in all study groups
Outcome measures
| Measure |
Group 1C
n=6 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2B
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
Group 2C
n=6 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1D
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2D
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1E - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 150 mg
|
Group 1F - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 300 mg
|
Group 1E -Placebo
Participants without HIV, who received a single subcutaneous injection of placebo (1 mL)
|
Group 1F - Placebo
Participants without HIV, who received a single subcutaneous injection of placebo (2 mL)
|
Group 1A
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 3 mg/kg.
|
Group 1B
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of 3BNC117-LS in All Study Groups
|
61.98 Days (median half-life per group)
Interval 41.49 to 83.51
|
60.83 Days (median half-life per group)
Interval 54.1 to 98.85
|
45.45 Days (median half-life per group)
Interval 41.85 to 62.64
|
59.04 Days (median half-life per group)
Interval 57.6 to 64.41
|
52.44 Days (median half-life per group)
Interval 39.49 to 64.52
|
63.60 Days (median half-life per group)
Interval 53.82 to 76.65
|
67.59 Days (median half-life per group)
Interval 49.69 to 78.26
|
—
|
—
|
76.33 Days (median half-life per group)
Interval 69.31 to 107.3
|
58.81 Days (median half-life per group)
Interval 51.48 to 59.0
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Groups 1E placebo and 1F placebo were not analyzed as they did not received the investigational product
number of participants with induced Anti-3BNC117-LS antibodies in all study groups
Outcome measures
| Measure |
Group 1C
n=6 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2B
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
Group 2C
n=6 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1D
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2D
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1E - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 150 mg
|
Group 1F - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 300 mg
|
Group 1E -Placebo
Participants without HIV, who received a single subcutaneous injection of placebo (1 mL)
|
Group 1F - Placebo
Participants without HIV, who received a single subcutaneous injection of placebo (2 mL)
|
Group 1A
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 3 mg/kg.
|
Group 1B
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Induced Anti-3BNC117-LS Antibodies in All Study Groups.
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 weeksAdverse events include signs, symptoms and laboratory abnormalities
Outcome measures
| Measure |
Group 1C
n=6 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2B
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
Group 2C
n=6 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1D
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 2D
n=3 Participants
Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1E - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 150 mg
|
Group 1F - 3BNC117-LS
n=6 Participants
Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 300 mg
|
Group 1E -Placebo
n=2 Participants
Participants without HIV, who received a single subcutaneous injection of placebo (1 mL)
|
Group 1F - Placebo
n=2 Participants
Participants without HIV, who received a single subcutaneous injection of placebo (2 mL)
|
Group 1A
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 3 mg/kg.
|
Group 1B
n=3 Participants
Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Who Experience Adverse Events During Study Follow-up
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Group 1A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 1C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 1D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2D
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1E 3BNC117-LS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1F 3BNC117-LS
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 1E Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 1F Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1A
n=3 participants at risk
Group 1A - Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 3 mg/kg.
|
Group 1B
n=3 participants at risk
Group 1B - Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
Group 1C
n=6 participants at risk
Group 1C - Participants without HIV, who received a single intravenous infusion of 3BNC117-LS 30 mg/kg.
|
Group 2B
n=3 participants at risk
Group 2B - Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS 10 mg/kg.
|
Group 2C
n=6 participants at risk
Group 2C - Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1D
n=3 participants at risk
Group 1D: participants without HIV who received a single intravenous dose of 3BNC117-LS at 30 mg/kg
|
Group 2D
n=3 participants at risk
Group 2C - Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS 30 mg/kg.
|
Group 1E 3BNC117-LS
n=6 participants at risk
Group 1E - Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 150 mg
|
Group 1F 3BNC117-LS
n=6 participants at risk
Group 1F - Participants without HIV, who received a single subcutaneous injection of placebo
|
Group 1E Placebo
n=2 participants at risk
Group 1E placebo - Participants without HIV, who received a single subcutaneous of 1ml placebo
.
|
Group 1F Placebo
n=2 participants at risk
Group 1F placebo - Participants without HIV, who received a single subcutaneous of 2ml placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
Other adverse events
| Measure |
Group 1A
n=3 participants at risk
Group 1A - Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 3 mg/kg.
|
Group 1B
n=3 participants at risk
Group 1B - Participants without HIV, who received a single intravenous infusion of 3BNC117-LS at 10 mg/kg.
|
Group 1C
n=6 participants at risk
Group 1C - Participants without HIV, who received a single intravenous infusion of 3BNC117-LS 30 mg/kg.
|
Group 2B
n=3 participants at risk
Group 2B - Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS 10 mg/kg.
|
Group 2C
n=6 participants at risk
Group 2C - Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS at 30 mg/kg.
|
Group 1D
n=3 participants at risk
Group 1D: participants without HIV who received a single intravenous dose of 3BNC117-LS at 30 mg/kg
|
Group 2D
n=3 participants at risk
Group 2C - Participants with HIV on ART, who received a single intravenous infusion of 3BNC117-LS 30 mg/kg.
|
Group 1E 3BNC117-LS
n=6 participants at risk
Group 1E - Participants without HIV, who received a single subcutaneous injection of 3BNC117-LS at 150 mg
|
Group 1F 3BNC117-LS
n=6 participants at risk
Group 1F - Participants without HIV, who received a single subcutaneous injection of placebo
|
Group 1E Placebo
n=2 participants at risk
Group 1E placebo - Participants without HIV, who received a single subcutaneous of 1ml placebo
.
|
Group 1F Placebo
n=2 participants at risk
Group 1F placebo - Participants without HIV, who received a single subcutaneous of 2ml placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Genitourinary chlamydia infection
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 2 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Investigations
Albumin urine present
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Investigations
Glucose tolerance impaired
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
50.0%
1/2 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Investigations
Hypokalaemia
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
50.0%
1/2 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Cardiac disorders
Elevated blood pressure
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Eye disorders
Chalazion
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
50.0%
1/2 • Number of events 1 • 48 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
General disorders
Injection site tenderness
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
50.0%
1/2 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
General disorders
Fatigue
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
General disorders
Infusion site haematoma
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
General disorders
Dizziness
|
0.00%
0/3 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
66.7%
2/3 • Number of events 2 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
1/3 • Number of events 1 • 48 weeks
|
0.00%
0/3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
0.00%
0/2 • 48 weeks
|
Additional Information
Marina Caskey, Professor of Clinical Investigation
Rockefeller University
Phone: 2123277396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place