Study of CM310 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: CM310; Drug: Placebo

• Registration Number: NCT06161090
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-03
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Status Verified: 2023-11
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 600 mg	CM310	CM310 Recombinant Humanized Monoclonal Antibody Injection
Placebo	Placebo	Placebo, Subcutaneous
Group 300 mg	CM310	CM310 Recombinant Humanized Monoclonal Antibody Injection
Group 75 mg	CM310	CM310 Recombinant Humanized Monoclonal Antibody Injection
Group 150 mg	CM310	CM310 Recombinant Humanized Monoclonal Antibody Injection

Primary Outcome Measures

Name	Time	Method
Adverse event	up to Week 9	Incidence of adverse events.

Trial Locations

Locations (1)

PKUCare Luzhong Hospital; 🇨🇳 Zibo, China