Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects (NCT07301203) | Clinical Trial Compass
RecruitingPhase 1
Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects
China90 participantsStarted 2025-10-21
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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;
What they're measuring
1
Safety outcomes
Timeframe: 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.
✕. 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;