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NCT04173819 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults
A Phase 1 study, sponsored by International AIDS Vaccine Initiative.
- Completed
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
NCT04173819: Completed Phase 1 study, sponsored by International AIDS Vaccine Initiative.
NCT04173819 is a Phase 1 study that has completed, run by International AIDS Vaccine Initiative. The registered enrollment target is 225 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04173819, a Phase 1 study, has completed, sponsored by International AIDS Vaccine Initiative.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
Study Summary
This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels \>10 µg/ml for at least 3 months in HIV-uninfected participants.
Interventions
- BIOLOGICAL 3BNC117-LS-J
- BIOLOGICAL 10-1074-LS-J
- BIOLOGICAL Combination 3BNC117-LS-J and 10-1074-LS-J
- BIOLOGICAL Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1
- BIOLOGICAL Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
What the finished NCT04173819 record still lists
NCT04173819 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher).
The record links to 0 conditions, and to 5 interventions - of which 3BNC117-LS-J is the first listed.
NCT04173819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04173819 about?
NCT04173819 is a clinical study titled "Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults". This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The ...
What is the current status of trial NCT04173819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2019-01-25. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT04173819?
The interventions under investigation include: 3BNC117-LS-J (BIOLOGICAL), 10-1074-LS-J (BIOLOGICAL), Combination 3BNC117-LS-J and 10-1074-LS-J (BIOLOGICAL), Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1 (BIOLOGICAL), Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04173819?
This trial is sponsored by International AIDS Vaccine Initiative, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04173819's enrollment target sits among peer trials
225 223rd of 2000 higher than 1,774 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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