Status:
COMPLETED
Single Ascending Dose Study of CM338 in Healthy Volunteers
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity...
Detailed Description
The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period. Sixty-six healthy volunteers will be enrolled and randomized ...
Eligibility Criteria
Inclusion
- with the ability to understand this study and voluntarily sign the informed consent form.
- 18 to 65 years of age.
- with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
- able to communicate with the researchers and follow the requirements specified in the protocol.
- agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.
Exclusion
- plan to conduct any major surgery during the study.
- known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
- with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.
Key Trial Info
Start Date :
December 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05186285
Start Date
December 11 2021
End Date
July 27 2022
Last Update
November 8 2024
Active Locations (1)
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1
PKUCare Luzhong Hospital
Zibo, Shandong, China