Multiple Ascending Dose Study of CM338 in Healthy Volunteers

Keymed Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: CM338 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05371379

CM338-100002

Details and patient eligibility

About

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.

Full description

The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

48 participants in 5 patient groups, including a placebo group

CM338 75 mg, subcutaneous injection

Experimental group

Description:

Qquaque week

Treatment:

Biological: CM338 Injection

CM338 150 mg, subcutaneous injection

Experimental group

Description:

Qquaque week

Treatment:

Biological: CM338 Injection

CM338 300 mg, subcutaneous injection

Experimental group

Description:

Qquaque week

Treatment:

Biological: CM338 Injection

CM338 300 mg, intravenous infusion

Experimental group

Description:

Qquaque week

Treatment:

Biological: CM338 Injection

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Biological: CM338 Injection