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Multiple Ascending Dose Study of CM338 in Healthy Volunteers

NCT05371379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-10-15

No results posted yet for this study

Summary

This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

Conditions

  • Healthy Subjects

Interventions

BIOLOGICAL

CM338 Injection

A humanized monoclonal antibody.

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
2022-05-24
Primary Completion
2022-11-04
Completion
2022-11-04

Countries

  • China

Study Locations

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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 NCT05371379 on ClinicalTrials.gov