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NCT05371379 | Not yet recruiting | Healthy Subjects

Multiple Ascending Dose Study of CM338 in Healthy Volunteers
Sponsor:

Keymed Biosciences Co.Ltd

Brief Summary:

This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

Condition or disease

Healthy Subjects

Intervention/treatment

CM338 Injection

Phase

Phase 1

Detailed Description:

The study included screening period, administration and safety follow-up period. Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.}}

Study Type : Interventional
Estimated Enrollment : 48 participants
Masking : Quadruple
Primary Purpose : Treatment
Official Title : A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022
Arm Intervention/treatment

Experimental: CM338 75 mg, subcutaneous injection

Qquaque week

Biological: CM338 Injection

Experimental: CM338 150 mg, subcutaneous injection

Qquaque week

Biological: CM338 Injection

Experimental: CM338 300 mg, subcutaneous injection

Qquaque week

Biological: CM338 Injection

Experimental: CM338 300 mg, intravenous infusion

Qquaque week

Biological: CM338 Injection

Placebo Comparator: Placebo

placebo

Biological: CM338 Injection
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Healthy male volunteers, aged ≥18 and ≤65 years.
  • Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
  • All clinical laboratory examination are normal, or abnormal without clinical significance.
Exclusion Criteria
  • Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
  • Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
  • Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
  • Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
Multiple Ascending Dose Study of CM338 in Healthy Volunteers

Location Details

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Multiple Ascending Dose Study of CM338 in Healthy Volunteers

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations