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Healthy

Single Ascending Dose Study of CM338 in Healthy Volunteers

Sponsored by Keymed Biosciences Co.Ltd

About this trial

Last updated 3 years ago

Study ID

CM338HV001

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 65 Years
Male
Male

Trial Timing

Ended 3 years ago

What is this trial about?

This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

What are the participation requirements?

Yes

Inclusion Criteria

- with the ability to understand this study and voluntarily sign the informed consent form.

- 18 to 65 years of age.

- with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.

- able to communicate with the researchers and follow the requirements specified in the protocol.

- agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.

No

Exclusion Criteria

- plan to conduct any major surgery during the study.

- known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.

- with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.

Locations

Location

Status

Recruiting