Single Ascending Dose Study of CM326 in Healthy Volunteers

A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.

Key Inclusion Criteria:

• 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 Criteria:

• 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.