Study of CM559 in Healthy Subjects

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-06-30

Brief Summary

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This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.

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Detailed Description

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Conditions

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Healthy Subjects

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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CM559 or matched placebo cohort 1

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injection administered IV, once.

CM559

Intervention Type BIOLOGICAL

CM559 injection administered IV, once.

CM559 or matched placebo cohort 2

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injection administered IV, once.

CM559

Intervention Type BIOLOGICAL

CM559 injection administered IV, once.

CM559 or matched placebo cohort 3

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injection administered IV, once.

CM559

Intervention Type BIOLOGICAL

CM559 injection administered IV, once.

CM559 or matched placebo cohort 4

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injection administered IV, once.

CM559

Intervention Type BIOLOGICAL

CM559 injection administered IV, once.

CM559 or matched placebo cohort 5

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injection administered IV, once.

CM559

Intervention Type BIOLOGICAL

CM559 injection administered IV, once.

Interventions

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Placebo

Placebo injection administered IV, once.

Intervention Type DRUG

CM559

CM559 injection administered IV, once.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects age ≥ 18 years \& ≤60 years.
* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria

* The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
* Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
* History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
* Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening.
* Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
* Severe trauma or undergo major surgery within 3 months prior to screening,or planned surgery during the research period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes