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NCT05184452 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT05184452 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 95 participants.
The verdict
NCT05184452, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.
Interventions
- DRUG PGDM1400LS (5mg/kg, IV)
- DRUG PGDM1400LS (20mg/kg, IV)
- DRUG PGDM1400LS (20mg/kg, SC)
- DRUG PGDM1400LS (40mg/kg, IV)
- DRUG PGDM1400LS (40mg/kg, SC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2023-07-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05184452
The ClinicalTrials.gov registry entry for NCT05184452 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which PGDM1400LS (5mg/kg, IV) is the first listed.
NCT05184452 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05184452 about?
NCT05184452 is a clinical study titled "A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants". Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to ...
What is the current status of trial NCT05184452?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2021-11-15. Estimated completion is 2023-07-19.
What interventions are being tested in trial NCT05184452?
The interventions under investigation include: PGDM1400LS (5mg/kg, IV) (DRUG), PGDM1400LS (20mg/kg, IV) (DRUG), PGDM1400LS (20mg/kg, SC) (DRUG), PGDM1400LS (40mg/kg, IV) (DRUG), PGDM1400LS (40mg/kg, SC) (DRUG).
Who is sponsoring clinical trial NCT05184452?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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