Single Ascending Dose Study of CM338 in Healthy Volunteers

A Single-dose, Randomized, Double Blind, Placebo-controlled, Dose-increasing Study to Evaluate the Safety, Tolerability, PK Characteristics, PD Effect, and Immunogenicity of CM338 Injection in Healthy Subjects.

This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: CM338

Detailed Description

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

Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Zibo, Shandong, 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:

• with the ability to understand this study and voluntarily sign the informed consent form.
• 18 to 65 years of age.
• with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
• able to communicate with the researchers and follow the requirements specified in the protocol.
• agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.

Exclusion Criteria:

• plan to conduct any major surgery during the study.
• known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
• with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM338 30mg, IV; 30mg, single dose, IV	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 60mg, IV; 60mg, single dose, IV	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 120mg, IV; 120mg, single dose, IV	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 240mg, IV; 240mg, single dose, IV	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 240mg, SC; 240mg, single dose, SC	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 480mg, IV; 480mg, single dose, IV	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 600mg, IV; 600mg, single dose, IV	Drug: CM338; CM338 : a humanized monoclonal antibody.
Experimental: CM338 600mg, SC; 600mg, single dose, SC	Drug: CM338; CM338 : a humanized monoclonal antibody.
Placebo Comparator: Placebo; Placebo, single dose, IV or SC	Drug: Placebo; Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety : Incidence of Adverse Events (AEs).	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Baseline up to Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)	Peak Plasma concentration (Cmax)	Baseline up to Day 57
Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)	Time to reach peak concentration (Tmax)	Baseline up to Day 57
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)	Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)	Baseline up to Day 57
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t)	Area under the plasma concentration-time curve from 0 to t (AUC0-t)	Baseline up to Day 57
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)	Clearance rate (CL/F)	Baseline up to Day 57
Bioavailability : bioavailability of CM338 with SC	The bioavailability of CM338 with SC	Baseline up to Day 57
Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.	C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.	Baseline up to Day 57
Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum.	The content of mannose-binding lectin serine protease 2 (MASP-2) in serum.	Baseline up to Day 57
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).	Proportion of subjects with anti-drug antibody (ADA).	Baseline up to Day 57

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2021
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CM338HV001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No