Single Ascending Dose Study of CM338 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186285
• Other study ID #: CM338HV001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 11, 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: 028-88610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CM338
CM338 : a humanized monoclonal antibody.
• Placebo
Placebo.

Locations

Country	Name	City	State
China	PKUCare Luzhong Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)	Peak Plasma concentration (Cmax)	Baseline up to Day 57
Secondary	Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)	Time to reach peak concentration (Tmax)	Baseline up to Day 57
Secondary	Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to 8 (AUC0-8)	Area under the plasma concentration-time curve from 0 to 8 (AUC0-8)	Baseline up to Day 57
Secondary	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
Secondary	Pharmacokinetics (PK) parameter : Clearance rate (CL/F)	Clearance rate (CL/F)	Baseline up to Day 57
Secondary	Bioavailability : bioavailability of CM338 with SC	The bioavailability of CM338 with SC	Baseline up to Day 57
Secondary	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
Secondary	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
Secondary	Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).	Proportion of subjects with anti-drug antibody (ADA).	Baseline up to Day 57