Back to resultsStudy 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)
Primary Purpose
Human Immunodeficiency Virus (HIV)
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Budigalimab
Placebo
Budigalimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus (HIV) focused on measuring Human Immunodeficiency Virus (HIV), Budigalimab, ABBV-181
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.
Sites / Locations
- Franco Felizarta, Md /Id# 223931
- Ruane Clinical Research Group /ID# 224496
- Quest Clinical Research /ID# 223925
- Central Texas Clinical Research /ID# 223937
- St. Hope Foundation, Inc. /ID# 224492
- North TX Infectious Diseases /ID# 224494
- The Crofoot Research Center, Inc /ID# 224493
- Peter Shalit, M.D. /ID# 224801
- Ponce Medical School Foundation /ID# 224230
- Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: Placebo SC + Placebo IV
Group 2: Budigalimab (SC) + Placebo IV
Group 3: Budigalimab SC + Placebo IV
Group 4: Placebo SC + Budigalimab IV
Arm Description
Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.
Outcomes
Primary Outcome Measures
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.
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.
Maximum Serum Concentration (Cmax)
Maximum Serum Concentration (Cmax) of Budigalimab.
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
Area Under the Plasma Concentration-time Curve (AUC).
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
Terminal phase elimination half-life (t1/2)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04799353
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
Human Immunodeficiency Virus (HIV), Budigalimab, ABBV-181
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Placebo SC + Placebo IV
Arm Type
Experimental
Arm Description
Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.
Arm Title
Group 2: Budigalimab (SC) + Placebo IV
Arm Type
Experimental
Arm Description
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Arm Title
Group 3: Budigalimab SC + Placebo IV
Arm Type
Experimental
Arm Description
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
Arm Title
Group 4: Placebo SC + Budigalimab IV
Arm Type
Experimental
Arm Description
Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.
Intervention Type
Drug
Intervention Name(s)
Budigalimab
Other Intervention Name(s)
ABBV-181
Intervention Description
Subcutaneous (SC)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous (SC)
Intervention Type
Drug
Intervention Name(s)
Budigalimab
Other Intervention Name(s)
ABBV-181
Intervention Description
Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous (IV)
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 24 weeks
Title
Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)
Description
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.
Time Frame
Up to approximately 24 weeks
Title
Maximum Serum Concentration (Cmax)
Description
Maximum Serum Concentration (Cmax) of Budigalimab.
Time Frame
Up to approximately 24 weeks
Title
Time to Maximum Observed Plasma Concentration (Tmax)
Description
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Time Frame
Up to approximately 24 weeks
Title
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
Description
Area Under the Plasma Concentration-time Curve (AUC).
Time Frame
Up to approximately 24 weeks
Title
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Up to approximately 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Franco Felizarta, Md /Id# 223931
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Ruane Clinical Research Group /ID# 224496
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Quest Clinical Research /ID# 223925
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-3037
Country
United States
Facility Name
Central Texas Clinical Research /ID# 223937
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-3326
Country
United States
Facility Name
St. Hope Foundation, Inc. /ID# 224492
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401-4528
Country
United States
Facility Name
North TX Infectious Diseases /ID# 224494
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Crofoot Research Center, Inc /ID# 224493
City
Houston
State/Province
Texas
ZIP/Postal Code
77098-3900
Country
United States
Facility Name
Peter Shalit, M.D. /ID# 224801
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-3595
Country
United States
Facility Name
Ponce Medical School Foundation /ID# 224230
City
Ponce
ZIP/Postal Code
00716-0377
Country
Puerto Rico
Facility Name
Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
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