Single Ascending Dose Study of CM338 in Healthy Volunteers

Keymed Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: CM338

Study type: Interventional

Funder types: Industry

Identifiers

NCT05186285

CM338HV001

Details and patient eligibility

About

This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

Full description

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

Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.

Enrollment: 66 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• with the ability to understand this study and voluntarily sign the informed consent form.
• 18 to 65 years of age.
• with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
• able to communicate with the researchers and follow the requirements specified in the protocol.
• agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.

Exclusion criteria

• plan to conduct any major surgery during the study.
• known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
• with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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66 participants in 9 patient groups, including a placebo group

CM338 30mg, IV

Experimental group

Description:

30mg, single dose, IV

Treatment:

Drug: CM338

CM338 60mg, IV

Experimental group

Description:

60mg, single dose, IV

Treatment:

Drug: CM338

CM338 120mg, IV

Experimental group

Description:

120mg, single dose, IV

Treatment:

Drug: CM338

CM338 240mg, IV

Experimental group

Description:

240mg, single dose, IV

Treatment:

Drug: CM338

CM338 240mg, SC

Experimental group

Description:

240mg, single dose, SC

Treatment:

Drug: CM338

CM338 480mg, IV

Experimental group

Description:

480mg, single dose, IV

Treatment:

Drug: CM338

CM338 600mg, IV

Experimental group

Description:

600mg, single dose, IV

Treatment:

Drug: CM338

CM338 600mg, SC

Experimental group

Description:

600mg, single dose, SC

Treatment:

Drug: CM338

Placebo

Placebo Comparator group

Description:

Placebo, single dose, IV or SC

Treatment:

Drug: Placebo