Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

Keymed Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05702450

CM310-100002

Details and patient eligibility

About

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Full description

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have the ability to understand the study.
• Voluntarily participate in the study and sign the ICF.
• 18 years ≤ age ≤ 65 years, male and female.
• Willing to take effective contraceptive measures during the study period.

Exclusion criteria

• Plan to receive any major surgery during the study period.
• With malignant tumors within 5 years before screening.
• Positive results of alcohol breath test or urine drug abuse screening during screening period.
• Any reason that the investigator believes that will prevent the subject from participating in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

Group P1

Experimental group

Description:

CM310, Subcutaneous

Treatment:

Biological: CM310

Group P2

Active Comparator group

Description:

CM310, Subcutaneous, as the parallel control group

Treatment:

Biological: CM310