Study of CM383 in Healthy Subjects

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CM383 Following Intravenous and Subcutaneous Administration in Healthy Adult Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07292688

Enrollment

Registered

2025-12-18

Start date

2026-01-01

Completion date

2026-07-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

BIOLOGICALCM383

CM383 subcutaneous injection, once.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 54 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects	Up to Day 85	Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax).

Countries

China

Contacts

CONTACTQian Jia

qianjia@keymedbio.com028-88610620

PRINCIPAL_INVESTIGATORBo Jiang

The Second Affiliated Hospital Zhejiang University School of Medcine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026