Study of CM383 in Healthy Subjects
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CM383 Following Intravenous and Subcutaneous Administration in Healthy Adult Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jan 2026
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
January 23, 2026
January 1, 2026
6 months
December 3, 2025
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects
Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax).
Up to Day 85
Study Arms (3)
CM383 subcutaneous injection group 1
EXPERIMENTALCM383 subcutaneous injection group 2
EXPERIMENTALCM383 intravenous infusion group
EXPERIMENTALInterventions
CM383 subcutaneous injection, once.
Eligibility Criteria
You may qualify if:
- Subjects age ≥ 18 years \& ≤54 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, China
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Jiang
The Second Affiliated Hospital Zhejiang University School of Medcine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2025
First Posted
December 18, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01