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Recruiting

NCT Number: NCT07292688

Study of CM383 in Healthy Subjects

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.

Recruiting

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Key information

Conditions

Age range

18 year–54 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM383

Biological

CM383 subcutaneous injection, once.

Primary outcomes

  1. Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects

    Time frame: Up to Day 85

    Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax).

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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