Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT06171048

CM310-100005

Details and patient eligibility

About

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Full description

This study includes screening and treatment and follow-up periods.

Enrollment: 236 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 years ≤ age ≤ 45 years.
• Voluntarily participate in the study and sign the ICF.
• Have the ability to understand the study.

Exclusion criteria

• With history of chronic or serious illness.
• With any medication within 28 days prior to administration;
• Plan to undergo surgery during the research period;
• With any situations unsuitable to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Group A

Experimental group

Description:

CM310 injection, Subcutaneous

Treatment:

Biological: CM310

Group B

Experimental group

Description:

CM310 injection, Subcutaneous

Treatment:

Biological: CM310