Clinical trial NCT04799353: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: Human Immunodeficiency Virus (HIV)
Budigalimab
ABBV-181
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Condition of generally good health, body mass index ≥ 18.0 to \< 35.0 kg/m2.
* Laboratory values must meet acceptable criteria.
* Human Immunodeficiency Virus (HIV-1) infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.
* CD4 cell count ≥ 450 cells/μL at Screening and during the 12 months prior to Screening.
* Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6 months prior to Screening.
* Participants agreeing to use an effective barrier method of protection (male and/or female condom) during sexual activity from Study Day 1 through last study visit for the purposes of prevention of HIV transmission.

Exclusion Criteria:

* Participants with signs/symptoms associated with SARS-CoV-2 infection OR Current SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to the Day 1 dose.
* Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome (AIDS)-defining illness.
* Participants having history of or active immunodeficiency (other than HIV).
* Participants having active autoimmune disease or history of autoimmune disease that has required systemic treatment.
* Prior therapy/exposure to budigalimab or any other immune checkpoint inhibitor \[e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4\].
* Participants having clinically significant medical disorders that might expose the subjects to undue risk of harm, confound study outcomes, or prevent the subject from completing the study.
* Participants having active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
* Participants with history of or active tuberculosis (TB) at screening.
* Participants having known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
* Participants who have received immunomodulatory or immunosuppressive (including IV/orally administered \[PO\] steroids at any dose, but excluding steroids that are inhaled, topical or via local injection) therapy within 24 weeks prior to the first dose of study drug.

Primary outcomes:
measure: Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
timeFrame: Up to approximately 24 weeks
measure: Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)
timeFrame: Up to approximately 24 weeks
measure: Maximum Serum Concentration (Cmax)
timeFrame: Up to approximately 24 weeks
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to approximately 24 weeks
measure: Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
timeFrame: Up to approximately 24 weeks
measure: Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
timeFrame: Up to approximately 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Franco Felizarta, Md /Id# 223931
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group /ID# 224496
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research /ID# 223925
state: California
city: Austin
country: United States
facility: Central Texas Clinical Research /ID# 223937
state: Texas
city: Bellaire
country: United States
facility: St. Hope Foundation, Inc. /ID# 224492
state: Texas
city: Dallas
country: United States
facility: North TX Infectious Diseases /ID# 224494
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, Inc /ID# 224493
state: Texas
city: Seattle
country: United States
facility: Peter Shalit, M.D. /ID# 224801
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation /ID# 224230
city: San Juan
country: Puerto Rico
facility: Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: