Study of CM313 in Healthy Subjects

Healthy Clinical Trial

Official title:

A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285227
• Other study ID #: CM313-100001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CM313 injection
CM313

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event	Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to week 12