Study of CM559 in Healthy Subjects
ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-60
SponsorKeymed Biosciences Co.Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects age ≥ 18 years & ≤60 years.
Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Placebo
DrugPlacebo injection administered IV, once.
CM559
Biological/VaccineCM559 injection administered IV, once.
Treatment groups
40 Participants
are divided into 5 treatment groupsGroup A: CM559 or matched placebo cohort 1Experimental treatment 2 interventions
Group B: CM559 or matched placebo cohort 2Experimental treatment 2 interventions
Group C: CM559 or matched placebo cohort 3Experimental treatment 2 interventions
Group D: CM559 or matched placebo cohort 4Experimental treatment 2 interventions
Group E: CM559 or matched placebo cohort 5Experimental treatment 2 interventions
Trial outcomes
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.
Time frame
Up to 99 DaysSponsors and contacts
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Source ClinicalTrials.gov