A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants

Inmagene LLC1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2022年7月5日最近更新: 2023年6月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Inmagene LLC
入组人数: 44
试验地点: 1
主要终点: Incidence and severity of treatment-emergent adverse events (TEAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This first in human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK)), and immunogenicity of a single ascending dose of IMG-007 in healthy participants.

详细描述

This study is a double-blind, randomized, placebo-controlled, sequential ascending, single dose escalating (SAD) study to assess the safety and PK profile of IMG-007 in healthy participants. The study is comprised of 3 phases: screening phase, treatment phase, and safety follow-up phase.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants aged between 18 to 50 years (inclusive)
•Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than 32 kg/m2 and a minimum body weight of 50 kg for males and 45 kg for females at both the Screening and Baseline visits.
•Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.

排除标准

•History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system
•History of immunological abnormality
•History of severe immediate hypersensitivity reaction to OX40 antagonists or other monoclonal antibodies
•History of anaphylaxis or significant reactions to foods, medications, or other allergens
•Major surgery ≤4 weeks before Baseline visit.
•History of malignancy or known current malignancy,
•Participant has an active infection or history of infections
•Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibody to Hepatitis B core antigen (HBcAb) with positive test for HBV DNA (>500 IU/ml) or hepatitis C antibodies (HCV) at Screening visit.
•History of asthma
•Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
•Participants with positive testing for COVID-19 at the Baseline visit.
•Participants with clinically significantly abnormal laboratory values, as determined by the Investigator or medically qualified designee, i
•Clinically significant abnormal findings at Screening or Baseline visits
•Systolic blood pressure below 100 mmHg, at any time points prior to IMP administration
•Use of any prescription medication
•Use of over-the-counter medication
•History of, or current substance abuse considered significant
•Use of more than 5 tobacco/nicotine-containing products
•Average alcohol consumption of more than 14 units/week for females and 21 units/week for males
•Receipt of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to Day 1 dosing.
•Live (attenuated) vaccination within 8 weeks before Screening or plan to be vaccinated by live (attenuated) vaccine during the trial
•COVID-19 vaccination, or influenza vaccination(inactivated), within 14 days prior or planning to receive COVID-19 vaccination or influenza vaccination(inactivated) within 14 days post IMP administration.
•Donated or lost more than 500 mL of blood or plasma within 3 months of Screening or received blood products within 8 weeks of Screening.
•Pregnant or lactating women.