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NCT06161090 Clinical Trial

Study of CM310 in Healthy Subjects

Healthy Clinical Trial

Official title:
Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06161090
Other study ID # CM310HV001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 3, 2019
Est. completion date January 13, 2020

Study information
Verified date November 2023
Source Keymed Biosciences Co.Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date January 13, 2020
Est. primary completion date January 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy male volunteers. - aged = 18 and = 65 years old. - With all clinical laboratory examination normal. - Voluntary signing of the informed consent form. Exclusion Criteria: - With a history of asthma and allergic reactions. - With a history of conjunctivitis and keratitis, as well as previous medical conditions. - With positive results from alcohol breath or urine drug abuse testing.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
CM310 injection
Drug:
• Placebo
subcutaneous injection

Locations
Country Name City State
China PKUCare Luzhong Hospital Zibo

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse event Incidence of adverse events. up to Week 9
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