A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Ascending Doses of CM583 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM583 in healthy adult participants. Approximately 40 participants will be enrolled in five dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive a single subcutaneous dose of CM583 or placebo.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age ≥ 18 years & ≤45 years.
- •Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
排除标准
- •The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
- •Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
- •History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
- •Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening.
- •Suspected allergy to CGRP(Calcitonin Gene-Related Peptide)- or PACAP(Pituitary Adenylate Cyclase-Activating Polypeptide)-targeting antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
- •Severe trauma or undergo major surgery within 3 months prior to screening, or planned surgery during the research period.
研究组 & 干预措施
CM583 or matched placebo cohort 1
干预措施: CM583 (Biological)
CM583 or matched placebo cohort 1
干预措施: Placebo (Drug)
CM583 or matched placebo cohort 2
干预措施: CM583 (Biological)
CM583 or matched placebo cohort 2
干预措施: Placebo (Drug)
CM583 or matched placebo cohort 3
干预措施: CM583 (Biological)
CM583 or matched placebo cohort 3
干预措施: Placebo (Drug)
CM583 or matched placebo cohort 4
干预措施: CM583 (Biological)
CM583 or matched placebo cohort 4
干预措施: Placebo (Drug)
CM583 or matched placebo cohort 5
干预措施: CM583 (Biological)
CM583 or matched placebo cohort 5
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Day 1 up to Day 169 or early discontinuation
TEAEs will be coded using Medical Dictionary for Regulatory Activities(MedDRA) and summarized by System Organ Class and Preferred Term. Serious, severe, treatment-related, fatal TEAEs and TEAEs leading to study withdrawal will also be summarized.
Number of Participants With Clinically Significant Physical Examination Abnormalities
时间窗: Day 1 up to Day 169 or early discontinuation
Physical examination findings judged to be clinically significant by the investigator will be summarized.
Number of Participants With Clinically Significant Vital Sign Abnormalities
时间窗: Day 1 up to Day 169 or early discontinuation
Vital sign assessments include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Clinically significant postbaseline abnormalities will be summarized.
Change From Baseline in Heart Rate, PR Interval, QRS Duration, QT Interval, QTcF Measured by 12-Lead Electrocardiogram
时间窗: Day 1 up to Day 169 or early discontinuation
Heart Rate, PR Interval, QRS Duration, QT Interval, QTcF (calculated as QT/RR\^0.33) will be measured using a 12-lead electrocardiogram.
Number of Participants With Clinically Significant Laboratory Test Abnormalities
时间窗: Day 1 up to Day 169 or early discontinuation
Laboratory assessments include hematology, blood chemistry, coagulation, lipid tests, and urinalysis. Clinically significant postbaseline abnormalities will be summarized.
次要结局
未报告次要终点