Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)
Public ClinicalTrials.gov record NCT04799353. 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 Randomized, Double-Blind, Placebo-controlled Single-Dose Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Administration of Budigalimab in Adult People Living With HIV-1 (PLWH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection. Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide. Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks. Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.
Study identification
- NCT ID
- NCT04799353
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 14, 2021
- Primary completion
- Oct 10, 2022
- Completion
- Oct 10, 2022
- Last update posted
- Oct 16, 2022
2021 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 3
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Franco Felizarta, Md /Id# 223931 | Bakersfield | California | 93301 | — |
| Ruane Clinical Research Group /ID# 224496 | Los Angeles | California | 90036 | — |
| Quest Clinical Research /ID# 223925 | San Francisco | California | 94115-3037 | — |
| Central Texas Clinical Research /ID# 223937 | Austin | Texas | 78705-3326 | — |
| St. Hope Foundation, Inc. /ID# 224492 | Bellaire | Texas | 77401-4528 | — |
| North TX Infectious Diseases /ID# 224494 | Dallas | Texas | 75246 | — |
| The Crofoot Research Center, Inc /ID# 224493 | Houston | Texas | 77098-3900 | — |
| Peter Shalit, M.D. /ID# 224801 | Seattle | Washington | 98104-3595 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04799353, 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 Oct 16, 2022 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04799353 live on ClinicalTrials.gov.