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Completed Phase 1 Interventional

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)

ClinicalTrials.gov ID: NCT04799353

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.

ClinicalTrials.gov public records Last synced May 11, 2026, 1:47 AM EDT

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)

Study identification

NCT ID
NCT04799353
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
AbbVie
Industry
Enrollment
33 participants

Conditions and interventions

Interventions

  • Budigalimab Drug
  • Placebo Drug

Drug

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 May 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04799353 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →