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NCT Number: NCT07175506

Study of CM559 in Healthy Subjects

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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Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location status: Recruiting

Location contact

Mengchang Yang

CONTACT

[email protected]

86+ 18140049936

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Placebo

Drug

Placebo injection administered IV, once.

CM559

Biological

CM559 injection administered IV, once.

Primary outcomes

  1. Safety and tolerability of single dose administration of CM559 in healthy male subjects: Adverse events (AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs), magnetic resonance imaging (MRI), laboratory tests, etc.

    Time frame: Up to 99 Days

    All adverse events (AEs) collected from all subjects from the time of signing the informed consent form (ICF) to the completion of the study (or early withdrawal), including clinical manifestations, severity, occurrence time, end time, treatment measures, and outcomes, as well as their correlation with the investigational drug.

    Any clinically significant abnormalities found during the physical examinations, vital signs examination, ECGs examinations and laboratory tests.

    The proportion of subjects experienced amyloid-related imaging abnormalities (ARIA) identified by MRI.

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 Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM559 in Healthy Subjects With Single Ascending Dose Administration

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 29, 2025

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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