Single Dose Escalation Study of CM383 in Healthy Volunteers

November 7, 2024 updated by: Keymed Biosciences Co.Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Qing Wen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
CM383 injection and matched placebo, intravenous injection
Other: Placebo
Placebo
Biological: CM383
CM383 Injection
Experimental: Group 2
CM383 injection and matched placebo, intravenous injection
Other: Placebo
Placebo
Biological: CM383
CM383 Injection
Experimental: Group 3
CM383 injection and matched placebo, intravenous injection
Other: Placebo
Placebo
Biological: CM383
CM383 Injection
Experimental: Group 4
CM383 injection and matched placebo, intravenous injection
Other: Placebo
Placebo
Biological: CM383
CM383 Injection
Experimental: Group 5
CM383 injection and matched placebo, intravenous injection
Other: Placebo
Placebo
Biological: CM383
CM383 Injection
Experimental: Group 6
CM383 injection and matched placebo, intravenous injection
Other: Placebo
Placebo
Biological: CM383
CM383 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to week 12
Incidence of adverse events.
Up to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Qing Wen, Jinan Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM383-100001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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