Single Ascending Dose Study of CM338 in Healthy Volunteers

NCT05186285 | Completed Phase 1

• 1 other identifier: CM338HV001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)

  Baseline up to Day 57

• Pharmacokinetics (PK) parameter : 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-∞)

  Baseline up to Day 57

• Pharmacokinetics (PK) parameter : 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)

  Baseline up to Day 57

Study Arms (9)

CM338 30mg, IV

EXPERIMENTAL

30mg, single dose, IV

Drug: CM338

CM338 60mg, IV

EXPERIMENTAL

60mg, single dose, IV

Drug: CM338

CM338 120mg, IV

EXPERIMENTAL

120mg, single dose, IV

Drug: CM338

CM338 240mg, IV

EXPERIMENTAL

240mg, single dose, IV

Drug: CM338

CM338 240mg, SC

EXPERIMENTAL

240mg, single dose, SC

Drug: CM338

CM338 480mg, IV

EXPERIMENTAL

480mg, single dose, IV

Drug: CM338

CM338 600mg, IV

EXPERIMENTAL

600mg, single dose, IV

Drug: CM338

CM338 600mg, SC

EXPERIMENTAL

600mg, single dose, SC

Drug: CM338

Placebo

PLACEBO COMPARATOR

Placebo, single dose, IV or SC

Drug: Placebo

Interventions

CM338 DRUG

CM338 : a humanized monoclonal antibody.

CM338 120mg, IV; CM338 240mg, IV; CM338 240mg, SC; CM338 30mg, IV; CM338 480mg, IV; CM338 600mg, IV; CM338 600mg, SC; CM338 60mg, IV

Placebo DRUG

Placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with the ability to understand this study and voluntarily sign the informed consent form.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 11, 2022
• Study Start: December 11, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: November 8, 2024

Record last verified: 2022-07

Locations

CN (1)