Single Dose Escalation Study of CM383 in Healthy Volunteers

Keymed Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer Disease

Treatments: Other: Placebo; Biological: CM383

Study type: Interventional

Funder types: Industry

Identifiers

NCT06412185

CM383-100001

Details and patient eligibility

About

This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.

Full description

Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.

Enrollment: 56 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males, voluntarily participate;
• 18 and 80 years old (including boundary values);
• able to communicate well with the researchers and follow up the protocol requirements.

Exclusion criteria

• The average daily smoking volume within three months before screening is greater than 5 cigarettes;
• Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
• Urine drug abuse screening is positive;
• Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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56 participants in 6 patient groups

Group 1

Experimental group

Description:

CM383 injection and matched placebo, intravenous injection

Treatment:

Biological: CM383

Other: Placebo

Group 2

Experimental group

Description:

CM383 injection and matched placebo, intravenous injection

Treatment:

Biological: CM383

Other: Placebo

Group 3

Experimental group

Description:

CM383 injection and matched placebo, intravenous injection

Treatment:

Biological: CM383

Other: Placebo

Group 4

Experimental group

Description:

CM383 injection and matched placebo, intravenous injection

Treatment:

Biological: CM383

Other: Placebo

Group 5

Experimental group

Description:

CM383 injection and matched placebo, intravenous injection

Treatment:

Biological: CM383

Other: Placebo

Group 6

Experimental group

Description:

CM383 injection and matched placebo, intravenous injection

Treatment:

Biological: CM383

Other: Placebo