Study of CM310 in Healthy Subjects

Keymed Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: CM310; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06161090

CM310HV001

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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33 participants in 5 patient groups, including a placebo group

Group 75 mg

Experimental group

Description:

CM310 Recombinant Humanized Monoclonal Antibody Injection

Treatment:

Biological: CM310

Group 150 mg

Experimental group

Description:

CM310 Recombinant Humanized Monoclonal Antibody Injection

Treatment:

Biological: CM310

Group 300 mg

Experimental group

Description:

CM310 Recombinant Humanized Monoclonal Antibody Injection

Treatment:

Biological: CM310

Group 600 mg

Experimental group

Description:

CM310 Recombinant Humanized Monoclonal Antibody Injection

Treatment:

Biological: CM310

Placebo

Placebo Comparator group

Description:

Placebo, Subcutaneous

Treatment:

Drug: Placebo