A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of VIB9600 by Intravenous Infusion or Subcutaneous Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single and multiple doses of VIB9600
研究概览
简要总结
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
详细描述
This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600.
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Investigator and subject are blinded, sponsor and site pharmacist are unblinded.
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
- 是
入选标准
- •Healthy male and female subjects aged 18 through 65 years at the time of consent.
- •Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg.
- •Females must have been surgically sterilized.
- •Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through to the final follow-up visit.
- •Able and willing to comply with the requirements of the protocol.
排除标准
- •Concurrent enrollment in another clinical study involving an investigational treatment.
- •Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1).
- •Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
- •History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening.
- •Positive test for drugs of abuse.
- •Donation of blood or blood products in excess of 500 mL within 3 months prior to screening. Not agreeing to refrain from blood or blood product donations during study participation.
- •Receiving any of the prohibited concomitant medications:
- •Any immunotherapy or immunosuppressive therapy
- •Chronic use of steroid medications
- •Immunoglobulin or blood products
- •Live vaccines
- •Anticoagulants
研究组 & 干预措施
VIB9600
Single dose of VIB9600 administered by IV infusion or SC injection.
Multiple dose VIB9600 administered by IV infusion every 2 weeks for 4 weeks.
干预措施: VIB9600 (Biological)
Placebo
Placebo comparator administered by slow IV infusion or SC injection.
干预措施: Placebos (Drug)
结局指标
主要结局
Safety and tolerability of single and multiple doses of VIB9600
时间窗: 113 days
Treatment-emergent adverse events that occur on or after the day of IP administration.
次要结局
- PK of VIB9600 following single- and multiple- dose administration(SAD- Days 1, 2, 3, 5, 8, 16, 29, 43, 57, 85, 113; MAD- Days 1, 3, 8, 15, 22, 29, 32, 36, 43, 57, 86, 113)
- Immunogenicity of VIB9600 following single- and multiple-dose administration.(SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113)