2025-520882-37-00招募中1 期
A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study of CMP-CPS-001 in Healthy Volunteers and Participants with Abnormal Heterozygous Ornithine Transcarbamylase (OTC) Genotype
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1. Incidence of AEs
研究概览
简要总结
- To evaluate the safety and tolerability of CMP-CPS-001 administered SC to study participants
研究设计
- 分配方式
- Randomized
- 主要目的
- Module 2 in female participants with an abnormal heterozygous OTC genotype
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Written consent obtained from the study participant and documented.
- •BMI ≥18.0 and ≤32 kg/m2 at screening, and ≤110 kg.
- •Module 1 Part C and Module 2: Participants must be female and must have confirmed heterozygous OTC genotype.
- •Module 1: Participants 18 to <65 years of age inclusive at time of informed consent.
- •Module 2: Participants 16 to <65 years of age inclusive at time of informed consent.
排除标准
- •Any significant disease or disorder which, in the opinion of the Investigator, may either put the study participant at risk because of participation in the study, may influence the results of the study, or may affect the study participant’s ability to participate in the study
- •Clinically relevant illness or infection within 7 days before the first dose of study drug that would risk integrity of the study, its data and/or participation, in the opinion of the Investigator.
- •History of intolerance to SC injection or relevant abdominal scarring.
- •Laboratory results outside of the normal ranges at screening and judged as clinically relevant by the Investigator for liver function, kidney function, and platelets.
- •Positive viral serology test results for HIV type 1 or 2 antibodies, hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
- •History of multiple drug allergies, history of serious anaphylaxis, or history of allergic reaction to oligonucleotides, GalNAc, polyethylene glycol, compound used for ureagenesis rate test, or other excipients.
- •Any other safety laboratory result considered clinically significant and unacceptable by the Investigator.
结局指标
主要结局
1. Incidence of AEs
1. Incidence of AEs
2. Vital signs
2. Vital signs
3. ECG
3. ECG
4. Clinical laboratory assessment
4. Clinical laboratory assessment
5. Physical examination
5. Physical examination
次要结局
- 1. Plasma concentration of CO-5122, the active ingredient of CMP-CPS-001
- 2. Calculated PK parameters
- 3. Urine concentration of CO-5122, the active ingredient of CMP-CPS-001
- 4. Ureagenesis rate test determinations
研究者
Yuri Maricich
Scientific
Camp4 Therapeutics Corp.
研究点 (1)
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