Study of CM313 in Healthy Subjects

Keymed Biosciences Co.Ltd51 enrolled

Overview

This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

CM313 injectionBIOLOGICAL

CM313

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects age ≥ 18 years \& ≤50 years. * Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: * With history of malignant tumors; * Plan to undergo major surgery during the research period * Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients; * With any voluntary blood donation or any other form of blood loss exceeding 400 mL; * The average daily smoking volume within the first three months of screening is greater than 5 cigarettes; * Positive results in baseline alcohol breath test or urine drug abuse screening.

Locations (1)

Huashan Hospital Fudan University

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Adverse event

Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame: Up to week 12

Central Contacts

Qian Jia

CONTACT

028-88610620 qianjia@keymedbio.com

Data from ClinicalTrials.gov

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