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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Condition of generally good health, body mass index ≥ 18.0 to < 35.0 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1: Placebo SC + Placebo IV
Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.
干预措施: Placebo (Drug)
Group 2: Budigalimab (SC) + Placebo IV
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
干预措施: Budigalimab (Drug)
Group 2: Budigalimab (SC) + Placebo IV
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
干预措施: Placebo (Drug)
Group 3: Budigalimab SC + Placebo IV
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
干预措施: Budigalimab (Drug)
Group 3: Budigalimab SC + Placebo IV
Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.
干预措施: Placebo (Drug)
Group 4: Placebo SC + Budigalimab IV
Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.
干预措施: Placebo (Drug)
Group 4: Placebo SC + Budigalimab IV
Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.
干预措施: Budigalimab (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
时间窗: Up to approximately 24 weeks
Area Under the Plasma Concentration-time Curve (AUC).
Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)
时间窗: Up to approximately 24 weeks
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)
时间窗: Up to approximately 24 weeks
Maximum Serum Concentration (Cmax) of Budigalimab.
Time to Maximum Observed Plasma Concentration (Tmax)
时间窗: Up to approximately 24 weeks
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
时间窗: Up to approximately 24 weeks.
Terminal phase elimination half-life (t1/2)
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
时间窗: Up to approximately 24 weeks
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.
次要结局
未报告次要终点