Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: CM310

• Registration Number: NCT05702450
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Detailed Description

This study includes screening and treatment and follow-up periods.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-27
• Study Start: 2023-03-22
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-26
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Have the ability to understand the study.
• Voluntarily participate in the study and sign the ICF.
• 18 years ≤ age ≤ 65 years, male and female.
• Willing to take effective contraceptive measures during the study period.

Exclusion Criteria

• Plan to receive any major surgery during the study period.
• With malignant tumors within 5 years before screening.
• Positive results of alcohol breath test or urine drug abuse screening during screening period.
• Any reason that the investigator believes that will prevent the subject from participating in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P1	CM310	CM310, Subcutaneous
Group P2	CM310	CM310, Subcutaneous, as the parallel control group

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic: the maximum concentration (Cmax)	up to 57 days	Concentration and exposure

Trial Locations

Locations (1)

PKUCare Luzhong Hospital; 🇨🇳 Zibo, China