Single Ascending Dose Study of CM326 in Healthy Volunteers

Keymed Biosciences

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: Placebo

Drug: CM326

Study type

Interventional

Funder types

Industry

Identifiers

NCT04842201

CM326HV001

Details and patient eligibility

About

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

Enrollment

44 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.