A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Inmagene LLC
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse Event Evaluation
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32 kg/m2, and a minimum body weight of 50 kg for males and 45 kg for females
- •Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- •Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.
- •Male participants who agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potentials or are surgically sterilized.
排除标准
- •Conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
- •Major surgery ≤ 4 weeks before the Baseline Visit or planned major surgical procedure during the study.
- •Use of any prescription medication (except for hormonal contraceptives for female participants within the 14 days prior to the first dose.
- •Drug or alcohol abuse.
- •Use of more than 5 tobacco/nicotine-containing products per month within 3 months of the first dose.
- •Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
- •Evidence of latent tuberculosis (TB) or a history of untreated or inadequately treated TB infection.
- •Receipt of a live/live attenuated vaccine within 2 months prior to Baseline Visit.
- •Hypersensitivity to study treatment or other biologics
- •Participation in prior IMG-007 study or another research study involving an investigational product within 30 days (small molecule) or 3 months (biological product), or 5 half-lives (whichever is longer) prior to the Baseline (Day 1) Visit.
研究组 & 干预措施
IMG-007 Cohort 1 (Healthy Participant)
Cohort 1 will receive a single subcutaneous dose of IMG-007 Dose 1 or matching placebo.
干预措施: IMG-007 (Drug)
IMG-007 Cohort 1 (Healthy Participant)
Cohort 1 will receive a single subcutaneous dose of IMG-007 Dose 1 or matching placebo.
干预措施: Placebo (Drug)
IMG-007 Cohort 2 (Healthy Participant)
Cohort 2 will receive a single subcutaneous dose of IMG-007 Dose 2 or matching placebo.
干预措施: IMG-007 (Drug)
IMG-007 Cohort 2 (Healthy Participant)
Cohort 2 will receive a single subcutaneous dose of IMG-007 Dose 2 or matching placebo.
干预措施: Placebo (Drug)
IMG-007 Cohort 3 (Healthy Participant)
Cohort 3 will receive a single subcutaneous dose of IMG-007 Dose 3 or matching placebo.
干预措施: IMG-007 (Drug)
IMG-007 Cohort 3 (Healthy Participant)
Cohort 3 will receive a single subcutaneous dose of IMG-007 Dose 3 or matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Event Evaluation
时间窗: Up to 18 weeks
Incidence of adverse events emergent from a single subcutaneous dose of IMG-007 in healthy participants.
次要结局
- Pharmacokinetic Parameters, Tmax(Up to 18 weeks)
- Pharmacokinetic Parameters, Cmax(Up to 18 weeks)
- Pharmacokinetic Parameters, AUC0-t(Up to 18 weeks)