Study of CM383 in Healthy Subjects

NCT ID: NCT07292688

Last Updated: 2025-12-18

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-07-31

Brief Summary

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This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM383 subcutaneous injection group 1

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 subcutaneous injection, once.

CM383 subcutaneous injection group 2

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 subcutaneous injection, once.

CM383 intravenous infusion group

Group Type EXPERIMENTAL

CM383

Intervention Type BIOLOGICAL

CM383 intravenous infusion, once.

Interventions

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CM383

CM383 subcutaneous injection, once.

Intervention Type BIOLOGICAL

CM383

CM383 intravenous infusion, once.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects age ≥ 18 years \& ≤54 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 400 mL, 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 6 months prior to screening, or planned surgery during the research period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Jiang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital Zhejiang University School of Medcine

Locations

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The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, , China

Site Status

Countries

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China

Central Contacts

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Qian Jia

Role: CONTACT

Phone: 028-88610620

Email: [email protected]

Facility Contacts

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Bo Jiang

Role: primary

Other Identifiers

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CM383-100002

Identifier Type: -

Identifier Source: org_study_id