Study of CM313 in Healthy Subjects

Keymed Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: CM313 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06285227

CM313-100001

Details and patient eligibility

About

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.

Enrollment: 51 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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51 participants in 4 patient groups

Group 1

Experimental group

Description:

CM313, subcutaneous injection, once

Treatment:

Biological: CM313 injection

Group 2

Experimental group

Description:

CM313, subcutaneous injection, once

Treatment:

Biological: CM313 injection

Group 3

Experimental group

Description:

CM313, subcutaneous injection, once

Treatment:

Biological: CM313 injection

Group 4

Experimental group

Description:

CM313, infusion, once

Treatment:

Biological: CM313 injection