Single Dose Escalation Study of CM383 in Healthy Volunteers

Alzheimer Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412185
• Other study ID #: CM383-100001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.

Description:

Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy males, voluntarily participate;
• 18 and 80 years old (including boundary values);
• able to communicate well with the researchers and follow up the protocol requirements.

Exclusion Criteria:

• The average daily smoking volume within three months before screening is greater than 5 cigarettes;
• Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
• Urine drug abuse screening is positive;
• Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• CM383
CM383 Injection

Other:
• Placebo
Placebo

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	Adverse events	Incidence of adverse events.	Up to week 12