Study of CM559 in Healthy Subjects

NCT07175506 | Recruiting Phase 1

• 1 other identifier: CM559-109001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

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.

  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.

  Up to 99 Days

Study Arms (5)

CM559 or matched placebo cohort 1

EXPERIMENTAL

Drug: Placebo; Biological: CM559

CM559 or matched placebo cohort 2

EXPERIMENTAL

Drug: Placebo; Biological: CM559

CM559 or matched placebo cohort 3

EXPERIMENTAL

Drug: Placebo; Biological: CM559

CM559 or matched placebo cohort 4

EXPERIMENTAL

Drug: Placebo; Biological: CM559

CM559 or matched placebo cohort 5

EXPERIMENTAL

Drug: Placebo; Biological: CM559

Interventions

Placebo DRUG

Placebo injection administered IV, once.

CM559 or matched placebo cohort 1; CM559 or matched placebo cohort 2; CM559 or matched placebo cohort 3; CM559 or matched placebo cohort 4; CM559 or matched placebo cohort 5

CM559 BIOLOGICAL

CM559 injection administered IV, once.

CM559 or matched placebo cohort 1; CM559 or matched placebo cohort 2; CM559 or matched placebo cohort 3; CM559 or matched placebo cohort 4; CM559 or matched placebo cohort 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

Study Officials

• Mengchang Yang

  Sichuan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CN (1)