Status:
COMPLETED
Multiple Ascending Dose Study of CM338 in Healthy Volunteers
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Healthy Subjects
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and im...
Detailed Description
The study included screening period, administration and safety follow-up period. Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.
Eligibility Criteria
Inclusion
- Healthy male volunteers, aged ≥18 and ≤65 years.
- Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
- All clinical laboratory examination are normal, or abnormal without clinical significance.
Exclusion
- Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
- Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
- Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
- Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05371379
Start Date
May 24 2022
End Date
November 4 2022
Last Update
October 15 2024
Active Locations (1)
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1
PKUCare Luzhong Hospital
Zibo, China