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
Public ClinicalTrials.gov record NCT05184452. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Dose-escalation 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
Study identification
- NCT ID
- NCT05184452
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NIH
- Enrollment
- 95 participants
Conditions and interventions
Conditions
Interventions
- PGDM1400LS (1.4g, IV) Drug
- PGDM1400LS (1.4g, SC) Drug
- PGDM1400LS (20mg/kg, IV) Drug
- PGDM1400LS (20mg/kg, SC) Drug
- PGDM1400LS (40mg/kg, IV) Drug
- PGDM1400LS (40mg/kg, SC) Drug
- PGDM1400LS (5mg/kg, IV) Drug
- PGT121.414.LS (1.4g, IV) Drug
- PGT121.414.LS (1.4g, SC) Drug
- PGT121.414.LS (20mg/kg, IV) Drug
- PGT121.414.LS (20mg/kg, SC) Drug
- PGT121.414.LS (40mg/kg, IV) Drug
- VRC07-523LS (1.4g, IV) Drug
- VRC07-523LS (1.4g, SC) Drug
- VRC07-523LS (20mg/kg, IV) Drug
- VRC07-523LS (20mg/kg, SC) Drug
- VRC07-523LS (40mg/kg, IV) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2021
- Primary completion
- Jul 18, 2023
- Completion
- Jul 18, 2023
- Last update posted
- Feb 9, 2025
2021 – 2023
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Bridge HIV CRS | San Francisco | California | 94102 | — |
| George Washington University | Washington D.C. | District of Columbia | 20037-1894 | — |
| The Hope Clinic of the Emory Vaccine Center | Atlanta | Georgia | 30030 | — |
| New Jersey Medical School Clinical Research Center CRS | Newark | New Jersey | 07103 | — |
| Vanderbilt Vaccine (VV) | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05184452, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 9, 2025 · Synced May 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05184452 live on ClinicalTrials.gov.