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)

Study Identifier
M19-972
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
  • Study Drug
  • Budigalimab
  • Placebo
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Franco Felizarta, Md /Id# 223931
    Bakersfield, California, United States, 93301
    Status
    Not applicable
    Location
    Ruane Clinical Research Group /ID# 224496
    Los Angeles, California, United States, 90036
    Status
    Not applicable
    Location
    Quest Clinical Research /ID# 223925
    San Francisco, California, United States, 94115-3037
    Status
    Not applicable
    Location
    Central Texas Clinical Research /ID# 223937
    Austin, Texas, United States, 78705-3326
    Status
    Not applicable
    Location
    St. Hope Foundation, Inc. /ID# 224492
    Bellaire, Texas, United States, 77401-4528
    Status
    Not applicable
    Location
    North TX Infectious Diseases /ID# 224494
    Dallas, Texas, United States, 75246
    Status
    Not applicable
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