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Single Ascending Dose Study of CM338 in Healthy Volunteers

NCT05186285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-11-08

No results posted yet for this study

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

Interventions

DRUG

CM338

CM338 : a humanized monoclonal antibody.

DRUG

Placebo

Placebo.

Sponsors & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-11
Primary Completion
2022-07-27
Completion
2022-07-27

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186285 on ClinicalTrials.gov