Study of CM383 in Healthy Subjects

Keymed Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: CM383

Study type: Interventional

Funder types: Industry

Identifiers

NCT07292688

CM383-100002

Details and patient eligibility

About

This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects age ≥ 18 years & ≤54 years.
• Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion criteria

• The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
• Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
• History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
• Blood donation or any other form of blood loss exceeding 400 mL, or accepting blood transfusion within 12 weeks prior to screening.
• Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
• Severe trauma or undergo major surgery within 6 months prior to screening, or planned surgery during the research period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

CM383 subcutaneous injection group 1

Experimental group

Treatment:

Biological: CM383

Biological: CM383

CM383 subcutaneous injection group 2

Experimental group

Treatment:

Biological: CM383

Biological: CM383

CM383 intravenous infusion group

Experimental group

Treatment:

Biological: CM383

Biological: CM383