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
Qualifiers
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
Treatments tested in this trial
- CM383
- CM383
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov