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)

NCT04799353 | Completed Phase 1 FDA Drug

• 1 other identifier: M19-972
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 10

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.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Human Immunodeficiency Virus (HIV); Budigalimab; ABBV-181

Outcome Measures

Primary Outcomes (6)

• Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.

  Up to approximately 24 weeks

• Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)

  Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines \[which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale\] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.

  Up to approximately 24 weeks

• Maximum Serum Concentration (Cmax)

  Maximum Serum Concentration (Cmax) of Budigalimab.

  Up to approximately 24 weeks

• Time to Maximum Observed Plasma Concentration (Tmax)

  Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.

  Up to approximately 24 weeks

• Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma

  Area Under the Plasma Concentration-time Curve (AUC).

  Up to approximately 24 weeks

• Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma

  Terminal phase elimination half-life (t1/2)

  Up to approximately 24 weeks.

Study Arms (4)

Group 1: Placebo SC + Placebo IV

EXPERIMENTAL

Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.

Drug: Placebo

Group 2: Budigalimab (SC) + Placebo IV

EXPERIMENTAL

Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.

Drug: Budigalimab; Drug: Placebo

Group 3: Budigalimab SC + Placebo IV

EXPERIMENTAL

Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.

Drug: Budigalimab; Drug: Placebo

Group 4: Placebo SC + Budigalimab IV

EXPERIMENTAL

Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.

Drug: Placebo; Drug: Budigalimab

Interventions

Budigalimab DRUG

Subcutaneous (SC)

Also known as: ABBV-181

Group 2: Budigalimab (SC) + Placebo IV; Group 3: Budigalimab SC + Placebo IV

Placebo DRUG

Subcutaneous (SC)

Group 1: Placebo SC + Placebo IV; Group 4: Placebo SC + Budigalimab IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Franco Felizarta, Md /Id# 223931

Bakersfield, California, 93301, United States

Location

Ruane Clinical Research Group /ID# 224496

Los Angeles, California, 90036, United States

Location

Quest Clinical Research /ID# 223925

San Francisco, California, 94115-3037, United States

Location

Central Texas Clinical Research /ID# 223937

Austin, Texas, 78705-3326, United States

Location

St. Hope Foundation, Inc. /ID# 224492

Bellaire, Texas, 77401-4528, United States

Location

North TX Infectious Diseases /ID# 224494

Dallas, Texas, 75246, United States

Location

The Crofoot Research Center, Inc /ID# 224493

Houston, Texas, 77098-3900, United States

Location

Peter Shalit, M.D. /ID# 224801

Seattle, Washington, 98104-3595, United States

Location

Ponce Medical School Foundation /ID# 224230

Ponce, 00716-0377, Puerto Rico

Location

Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936

San Juan, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

budigalimab

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: March 15, 2021
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); PR (2)