Single Ascending Dose Study of CM338 in Healthy Volunteers

Keymed Biosciences Co.Ltd66 enrolled

Overview

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.

The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period. Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

CM338DRUG

CM338 : a humanized monoclonal antibody.

PlaceboDRUG

Placebo.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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 (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

Outcomes

Primary Outcomes

Safety : Incidence of Adverse Events (AEs).

Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.