Multiple Ascending Dose Study of CM338 in Healthy Volunteers

A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Biological: CM338 Injection

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zibo, China
    • PKUcare Luzhong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo	Biological: CM338 Injection; A humanized monoclonal antibody.
Experimental: CM338 75 mg, subcutaneous injection; Qquaque week	Biological: CM338 Injection; A humanized monoclonal antibody.
Experimental: CM338 150 mg, subcutaneous injection; Qquaque week	Biological: CM338 Injection; A humanized monoclonal antibody.
Experimental: CM338 300 mg, subcutaneous injection; Qquaque week	Biological: CM338 Injection; A humanized monoclonal antibody.
Experimental: CM338 300 mg, intravenous infusion; Qquaque week	Biological: CM338 Injection; A humanized monoclonal antibody.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CM338-100002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No