Study of CM383 in Healthy Subjects
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-54
SponsorKeymed Biosciences Co.Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects age ≥ 18 years & ≤54 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 400 mL, or accepting blood transfusion within 12 weeks prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
CM383
Biological/VaccineCM383 subcutaneous injection, once.
CM383
Biological/VaccineCM383 intravenous infusion, once.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: CM383 subcutaneous injection group 1Experimental treatment 1 intervention
Group B: CM383 subcutaneous injection group 2Experimental treatment 1 intervention
Group C: CM383 intravenous infusion groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects
Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax).
Time frame
Up to Day 85Sponsors and contacts
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Source ClinicalTrials.gov