A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
概览
- 阶段
- 1 期
- 干预措施
- BION-1301 Multiple Doses
- 疾病 / 适应症
- IgA Nephropathy
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 103
- 试验地点
- 28
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
- 状态
- 进行中（未招募）
- 最后更新
- 12天前
概览
简要总结
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
详细描述
This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. The study will be conducted in three parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period Parts 1 and 2 have been completed. Part 3 enrollment is complete. Part 4 enrollment is open for eligible participants from Part 3. The study will enroll up to 40 participants with IgAN.
研究者
入排标准
入选标准
- •for Healthy Volunteers:
- •Healthy male or female volunteers, 18 to 55 years old
- •Females must be of non-childbearing potential
- •Males must agree to follow the protocol-specified contraception guidance
- •Body mass index (BMI) between 18 and 35 kg/m\^2, with a weight of at least 50 kg
- •Non-smoker, defined as an individual who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products at least 3 months before Screening
- •Able to provide signed informed consent
排除标准
- •for Healthy Volunteers:
- •Regular consumption of alcohol within 6 months prior to Screening, or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or urine test results for drugs of abuse or alcohol at Screening or Admission
- •Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7 days prior to the first dose of study drug, or platelets in the 6 weeks prior to the first dose of study drug
- •History or evidence of a clinically significant disorder, condition, or disease that could pose a risk to subject safety or interfere with the study, or would make the subject unsuitable for participation, eg, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or psychiatric disease
- •Female who is breastfeeding or who has a positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1
- •Inclusion Criteria for Adults with IgAN:
- •Male or female ≥18 years old at Screening
- •Women of child-bearing potential (WOCBP; per CTFG 2014) must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug)
- •Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug)
- •BMI between 18 and 40 kg/m\^2, inclusive, at Screening with a weight of at least 50 kg
研究组 & 干预措施
Part 2: BION-1301
Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion.
干预措施: BION-1301 Multiple Doses
Part 2: Placebo
Participants will receive placebo by IV infusion.
干预措施: Placebo Multiple Doses
Part 3: BION-1301
Two cohorts of participants will receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly.
干预措施: BION-1301 Multiple Doses
Part 1: BION-1301
Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion.
干预措施: BION-1301 Single Dose
Part 1: Placebo
Participants will receive a single dose of placebo administered by IV infusion.
干预措施: Placebo Single Dose
Part 4 Retreatment: BION-1301
Eligible participants from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly.
干预措施: BION-1301 Single Dose
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
时间窗: Participants followed from date of enrollment until the end of study, assessed up to 76 weeks.
Severity of TEAEs as assessed according to NCI-CTCAE
时间窗: Participants followed from date of enrollment until the end of study, assessed up to 76 weeks.