Single Dose Escalation Study of CM383 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

CM383 injection and matched placebo, intravenous injection

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 Injection

Placebo

Intervention Type OTHER

Placebo

Group 2

CM383 injection and matched placebo, intravenous injection

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 Injection

Placebo

Intervention Type OTHER

Placebo

Group 3

CM383 injection and matched placebo, intravenous injection

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 Injection

Placebo

Intervention Type OTHER

Placebo

Group 4

CM383 injection and matched placebo, intravenous injection

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 Injection

Placebo

Intervention Type OTHER

Placebo

Group 5

CM383 injection and matched placebo, intravenous injection

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 Injection

Placebo

Intervention Type OTHER

Placebo

Group 6

CM383 injection and matched placebo, intravenous injection

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 Injection

Placebo

Intervention Type OTHER

Placebo

Interventions

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CM383

CM383 Injection

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes