RECRUITINGPhase 1INTERVENTIONAL
Single Dose Escalation Study of CM383 in Healthy Volunteers
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects
About This Trial
This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.
Who May Be Eligible (Plain English)
Who May Qualify:
- Healthy males, voluntarily participate;
- 18 and 80 years old (including boundary values);
- able to communicate well with the researchers and follow up the protocol requirements.
Who Should NOT Join This Trial:
- The average daily smoking volume within three months before screening is greater than 5 cigarettes;
- Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
- Urine drug abuse screening is positive;
- Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Healthy males, voluntarily participate;
* 18 and 80 years old (including boundary values);
* able to communicate well with the researchers and follow up the protocol requirements.
Exclusion Criteria:
* The average daily smoking volume within three months before screening is greater than 5 cigarettes;
* Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
* Urine drug abuse screening is positive;
* Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
Treatments Being Tested
BIOLOGICAL
CM383
CM383 Injection
OTHER
Placebo
Placebo
Locations (1)
Jinan Central Hospital
Jinan, Shandong, China