A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Doses of CPD704 Inhalation Suspension in Healthy Chinese Adult Subjects.
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety outcomes
概览
简要总结
This is a Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of CPD704 inhalation suspension in healthy Chinese adult subjects.
详细描述
This study is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of CPD704 inhalation suspension administered via nebulization in healthy Chinese adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •The subject can communicate well with the researchers, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent form;
- •Healthy subjects aged 18-55 years (including the boundary value, subject to the time of signing the informed consent form), male or female;
- •Body mass index (BMI) within the range of 19 \~ 28 kg/m2 (including the critical value), male weight ≥ 50 kg, female weight ≥ 45 kg;
- •The subject has no plans to give birth, sperm or egg donation from the signing of the informed consent form to 90 days after medication, and voluntarily takes medically approved contraceptive measures (including his partner)
排除标准
- •Patients who have taken any clinical trial drugs or participated in any drug clinical trial within 3 months before signing the ICF, or participated in other medical research activities, and are not suitable for participating in this trial as judged by the investigator;
- •Previous or combined with the following diseases, cardiovascular disease \[such as heart failure (such as fluid retention and edema), unstable ischemic heart disease, congestive heart failure poor control of coronary artery disease, myocardial infarction, long QT syndrome history, etc.\], respiratory, renal, neurological, endocrine, immune, skin, gastrointestinal (such as gastrointestinal ulcers or gastrointestinal bleeding, etc.), liver or blood system and other diseases/abnormal history, the investigators judge that their participation in this trial may affect the safety of subjects or affect the analysis of study results;
- •Patients with the following mental illness: 1) Uncontrolled/unstable major depressive disorder (MDD) or other serious mental disorders (such as schizophrenia, bipolar disorder or other serious mood or anxiety disorders) within 2 years before screening; 2) Suicide attempt or suicidal behavior 30 times before screening; 3) Suicidal ideation corresponding to Columbia-Suicide Severity Rating Scale (C-SSRS) category 4 or 5 in the past 30;
- •Known hypersensitivity, immune reaction or intolerance to CPD704 Inhalation Suspension or any of the excipients in the drug product (polysorbate 80, sodium chloride, sodium citrate dihydrate, disodium edetate, sodium hydroxide or hydrochloric acid) and/or unsuitable for treatment with CPD704 Inhalation Suspension;
- •Long-term oral drugs can not be stopped or suffering from gastric ulcer, gastritis affecting oral activated charcoal, or allergic to activated charcoal;
- •Patients with severe infection, trauma or major surgery before signing the ICF, or planning to undergo surgery during the trial;
- •Use of any live vaccines (except influenza vaccine) within 28 days before signing the ICF or plan to receive vaccines during the study;
- •Blood loss or blood donation of more than 400 mL within 3 months before signing the ICF (excluding female menstrual blood loss), or intend to donate blood during the trial or within 1 month after the end of the trial;
- •Smokers or those who smoke more than 5 cigarettes per day within 3 months before signing the ICF, or those who cannot comply with the provisions of prohibiting smoking during the trial, or those who test positive for urine cotinine;
- •Pulmonary ventilation function test Forced expiratory volume in the first second (FEV1) measured value/FEV1 predicted value ≤ 80% or forced vital capacity (FVC) ≤ 80% of predicted value or any other clinically significant abnormalities;
研究组 & 干预措施
SAD 3mg
This group will include exploratory studies onmetabolite identification, excretion pathways, and excretion quantification(conducted in Cycle 1) as well as anactivated charcoal gastrointestinal absorption blockade study(conducted in Cycle 2). A total of12 subjects will be enrolled (10:2 =CPD704 treatment group: placebo group), Each subject will receive a single 3 mg dose per cycle via oral inhalation.
干预措施: CPD704 Inhalation Suspension (Drug)
SAD 0.5mg
For SAD 0.5mg cohort will enroll 2 subjects who will receive CPD704 once. 0.5 mg per administration
干预措施: CPD704 Inhalation Suspension (Drug)
SAD 1.5mg
The SAD 1.5mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant.1.5 mg per administration.
干预措施: CPD704 Inhalation Suspension (Drug)
SAD 1.5mg
The SAD 1.5mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant.1.5 mg per administration.
干预措施: CPD704 placebo (Other)
SAD 3mg
This group will include exploratory studies onmetabolite identification, excretion pathways, and excretion quantification(conducted in Cycle 1) as well as anactivated charcoal gastrointestinal absorption blockade study(conducted in Cycle 2). A total of12 subjects will be enrolled (10:2 =CPD704 treatment group: placebo group), Each subject will receive a single 3 mg dose per cycle via oral inhalation.
干预措施: CPD704 placebo (Other)
SAD 6mg
The SAD 6mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,6 mg per administration.
干预措施: CPD704 Inhalation Suspension (Drug)
SAD 6mg
The SAD 6mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,6 mg per administration.
干预措施: CPD704 placebo (Other)
SAD 9mg
The SAD 9mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,9 mg per administration.
干预措施: CPD704 Inhalation Suspension (Drug)
SAD 9mg
The SAD 9mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,9 mg per administration.
干预措施: CPD704 placebo (Other)
SAD 12mg
The SAD 12mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,12 mg per administration..
干预措施: CPD704 Inhalation Suspension (Drug)
SAD 12mg
The SAD 12mg cohort plans to enroll 10 subjects with 8 subjects receiving CPD704 and 2 subjects receiving placebo, administered as a single dose per participant,12 mg per administration..
干预措施: CPD704 placebo (Other)
MAD 1.5mg
Each cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation.
Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses).1.5 mg per administration.
干预措施: CPD704 Inhalation Suspension (Drug)
MAD 1.5mg
Each cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation.
Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses).1.5 mg per administration.
干预措施: CPD704 placebo (Other)
MAD 3mg
Each cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation.
Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses) . 3 mg per administration.
干预措施: CPD704 Inhalation Suspension (Drug)
MAD 3mg
Each cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation.
Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses) . 3 mg per administration.
干预措施: CPD704 placebo (Other)
MAD 6mg
Each cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation.
Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses). Each dose:6mg.
干预措施: CPD704 Inhalation Suspension (Drug)
MAD 6mg
Each cohort is planned to enroll 12 subjects (10:2 = CPD704 treatment group : placebo group). The route of administration is oral inhalation.
Based on SAD study results, the MAD cohort will receive QD or BID dosing, with a proposed 5-day consecutive dosing regimen (for BID dosing, only a morning dose will be administered on Day 5, totaling 9 doses). Each dose:6mg.
干预措施: CPD704 placebo (Other)
结局指标
主要结局
Safety outcomes
时间窗: From the date of informed consent signature until Day 7 for SAD group(Day 14 for SAD 3mg group) and Day 11 for MAD Group.
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.
次要结局
- Pharmacokinetic (PK) endpoints(During the period starting 60 minutes before initial drug administration through to 48hours after last dose)