Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
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 |
What the finished NCT05184452 record still lists
NCT05184452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 5 interventions - of which PGDM1400LS (5mg/kg, IV) is the first listed.
NCT05184452 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05184452's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03339128 · 95 participants · Phase 2
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
- NCT03509961 · 95 participants · Phase 2
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
- NCT03694756 · 95 participants · NA
TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
- NCT04206215 · 95 participants · NA
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI