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NCT03015181 · ClinicalTrials.gov registry record · Phase 1
VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03015181: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03015181 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03015181, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infected people. Objective: To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy adults. Eligibility: Healthy people ages 18-50 Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Participants will be assigned to 1 of 7 groups: Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks. Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48 weeks. Participants will get the drug in 1 of 2 ways: Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6 hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will have 4-5 visits in the week after their second and third doses. Injection into the fatty tissue under the skin. Participants will have blood tests before the injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits after the second and third doses. Visits include: Physical exam Blood and urine tests Optional oral swabs to collect saliva Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
Primary Outcome
Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they i
Interventions
- BIOLOGICAL VRC-HIVMAB075-00-AB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2018-07-10 |
| Phase | Phase 1 |
What the finished NCT03015181 record still lists
NCT03015181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which VRC-HIVMAB075-00-AB is the first listed.
NCT03015181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03015181 about?
NCT03015181 is a clinical study titled "VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults". Background: Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infec...
What is the current status of trial NCT03015181?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-02-21. Estimated completion is 2018-07-10.
What interventions are being tested in trial NCT03015181?
The interventions under investigation include: VRC-HIVMAB075-00-AB (BIOLOGICAL).
Who is sponsoring clinical trial NCT03015181?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03015181's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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