Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Biological: CM310

• Registration Number: NCT06171048
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Detailed Description

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

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14
• Study Start: 2024-04-30
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 236

Inclusion Criteria

• 20 years ≤ age ≤ 45 years.
• Voluntarily participate in the study and sign the ICF.
• Have the ability to understand the study.

Exclusion Criteria

• With history of chronic or serious illness.
• With any medication within 28 days prior to administration;
• Plan to undergo surgery during the research period;
• With any situations unsuitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	CM310	CM310 injection, Subcutaneous
Group A	CM310	CM310 injection, Subcutaneous

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic: the maximum concentration (Cmax)	up to week 6	Concentration and exposure

Trial Locations

Locations (1)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China