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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
CM559 or matched placebo cohort 5
Intervention: CM559 (Biological)
CM559 or matched placebo cohort 1
Intervention: Placebo (Drug)
CM559 or matched placebo cohort 3
Intervention: Placebo (Drug)
CM559 or matched placebo cohort 2
Intervention: Placebo (Drug)
CM559 or matched placebo cohort 1
Intervention: CM559 (Biological)
CM559 or matched placebo cohort 4
Intervention: Placebo (Drug)
CM559 or matched placebo cohort 5
Intervention: Placebo (Drug)
CM559 or matched placebo cohort 4
Intervention: CM559 (Biological)
CM559 or matched placebo cohort 3
Intervention: CM559 (Biological)
CM559 or matched placebo cohort 2
Intervention: CM559 (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported