Multiple Ascending Dose Study of CM338 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Biological: CM338 Injection

• Registration Number: NCT05371379
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

Detailed Description

The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Study Timeline

• Study First Submitted: 2022-05-07
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Study Start: 2022-05-24
• Primary Completion: 2022-11-04
• Study Completion: 2022-11-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Healthy male volunteers, aged ≥18 and ≤65 years.
• Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
• All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion Criteria

• Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
• Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
• Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
• Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CM338 300 mg, intravenous infusion	CM338 Injection	Qquaque week
CM338 75 mg, subcutaneous injection	CM338 Injection	Qquaque week
CM338 150 mg, subcutaneous injection	CM338 Injection	Qquaque week
CM338 300 mg, subcutaneous injection	CM338 Injection	Qquaque week
Placebo	CM338 Injection	placebo

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs).	Up to Week 12.	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Trial Locations

Locations (1)

PKUCare Luzhong Hospital; 🇨🇳 Zibo, China