Status:
COMPLETED
Single Ascending Dose Study of CM326 in Healthy Volunteers
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Asthma
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.
Eligibility Criteria
Inclusion
- Key
- Healthy adult male participant,18 to 65 years of age, inclusive.
- Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
- History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
- Males must abstain from sex or use highly effective methods of birth control.
- Having given written informed consent prior to undertaking any study-related procedure.
- Key
Exclusion
- Positive for HIV, or Hepatitis B, or C.
- Positive result on urine drug screen.
- Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
- With any condition that inappropriate for entry into this study.
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04842201
Start Date
April 13 2021
End Date
September 28 2021
Last Update
April 12 2022
Active Locations (1)
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1
PKUCare Luzhong Hospital
Zibo, Shandong, China