Multiple Ascending Dose Study of CM338 in Healthy Volunteers

Healthy Subjects Clinical Trial

Official title:

A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05371379
• Other study ID #: CM338-100002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2022
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers, aged =18 and =65 years.

• Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.

• All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion Criteria:

• Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.

• Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.

• Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.

• Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• CM338 Injection
A humanized monoclonal antibody.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs).	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Up to Week 12.