Healthy Subjects
Conditions
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 immunogenicity of CM338 with multiple dosing in healthy subjects.
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.
Interventions
BIOLOGICALCM338 Injection
A humanized monoclonal antibody.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs). | Up to Week 12. | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. |
Countries
China
Outcome results
None listed