Trials / Completed
CompletedNCT05171348
A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Ascending Doses of CM326 Injection by Subcutaneous Administration in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Keymed Biosciences Co.Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC administraion of CM326 at different doses in healthy subjects. 40 healthy male subjects will be enrolled in the study. The drug will be administered by dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM326 | a humanized monoclonal antibody |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2022-01-07
- Primary completion
- 2022-10-11
- Completion
- 2022-10-11
- First posted
- 2021-12-28
- Last updated
- 2023-06-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05171348. Inclusion in this directory is not an endorsement.