Skip to main content
Delfa

← Trials/Trial dossier/NCT06412185

UnknownPhase 1

Single Dose Escalation Study of CM383 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects

Asset

CM383

Listed sites

1

Recruiting sites

1

Enrollment

56

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-80•Male

Primary endpoint

•Adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCM383-100001
NCT IDNCT06412185

Timeline

Milestones

Study first posted2024-05-14actual
Study start2024-05-28actual
Last update posted2024-11-08actual
Primary completion2025-06-30estimated
Study completion2025-06-30estimated

Assets

Drug assets

CM383

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexMale
Healthy volunteersAccepted

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Adverse events

Time frame:Up to week 12

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.