Single Ascending Dose Study of CM338 in Healthy Volunteers

Sponsor

Keymed Biosciences Co.Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05186285

Collaborator

(none)

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: CM338 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 11, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Safety : Incidence of Adverse Events (AEs). [Baseline up to Day 57]
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PKUCare Luzhong Hospital	Zibo	Shandong	China

Sponsors and Collaborators

Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Keymed Biosciences Co.Ltd

ClinicalTrials.gov Identifier:

NCT05186285

Other Study ID Numbers:

CM338HV001

First Posted:

Jan 11, 2022

Last Update Posted:

Feb 11, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 11, 2022