Study of CM559 in Healthy Subjects

Keymed Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: CM559; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07175506

CM559-109001

Details and patient eligibility

About

This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects age ≥ 18 years & ≤60 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 400mL, 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 3 months prior to screening,or planned surgery during the research period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups

CM559 or matched placebo cohort 1

Experimental group

Treatment:

Drug: Placebo

Biological: CM559

CM559 or matched placebo cohort 2

Experimental group

Treatment:

Drug: Placebo

Biological: CM559

CM559 or matched placebo cohort 3

Experimental group

Treatment:

Drug: Placebo

Biological: CM559

CM559 or matched placebo cohort 4

Experimental group

Treatment:

Drug: Placebo

Biological: CM559

CM559 or matched placebo cohort 5

Experimental group

Treatment:

Drug: Placebo

Biological: CM559