Actively Recruiting
Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2025-12-24
90
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate well and understand the trial purpose, voluntarily consenting to participate
- Healthy males or females aged 18 to 55 years
- Body mass index between 19 and 28 kg/m2, with males weighing at least 50 kg and females at least 45 kg
- No plans for pregnancy or sperm/egg donation from consent until 90 days after dosing, with use of medically approved contraception
You will not qualify if you...
- Participation in any drug clinical trial or medical research within 3 months before consent
- History or presence of cardiovascular, respiratory, renal, neurological, endocrine, immune, skin, gastrointestinal, liver, or blood system diseases that may affect safety or study results
- Uncontrolled or serious mental illness within 2 years, recent suicidal behavior or ideation
- Known allergies or intolerance to CPD704 or its components
- Long-term oral drug use that cannot be stopped or gastrointestinal conditions affecting treatment
- Severe infection, trauma, or major surgery before consent or planned surgery during the trial
- Use of live vaccines (except influenza) within 28 days before consent or planned during the study
- Recent significant blood loss or donation
- Smoking more than 5 cigarettes per day within 3 months or inability to abstain during the trial
- Abnormal lung function test results or clinically significant abnormalities
- Use of drugs affecting liver enzymes or other medications within specified timeframes before consent
- Excessive caffeine intake within 6 months or caffeine-containing foods within 48 hours before dosing
- Special dietary requirements incompatible with study diet
- Inability or unwillingness to tolerate multiple blood draws or history of fainting
- History of drug abuse or positive drug screening
- Regular alcohol consumption exceeding limits or inability to abstain during the trial
- Abnormal physical exam, vital signs, ECG, lab tests, chest X-ray, or abdominal ultrasound judged clinically significant
- Abnormal ECG findings such as bradycardia, tachycardia, QTc prolongation, or arrhythmia
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Pregnant or breastfeeding women or positive pregnancy test
- Inability to correctly use the nebulizer or failure of inhalation training
- Any other condition judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
Research Team
Y
Yanru Yanru
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
9
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