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
1 other identifier
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 alzheimer-disease
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedStudy Start
First participant enrolled
May 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedNovember 8, 2024
May 1, 2024
1.1 years
May 9, 2024
November 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Incidence of adverse events.
Up to week 12
Study Arms (6)
Group 1
EXPERIMENTALCM383 injection and matched placebo, intravenous injection
Group 2
EXPERIMENTALCM383 injection and matched placebo, intravenous injection
Group 3
EXPERIMENTALCM383 injection and matched placebo, intravenous injection
Group 4
EXPERIMENTALCM383 injection and matched placebo, intravenous injection
Group 5
EXPERIMENTALCM383 injection and matched placebo, intravenous injection
Group 6
EXPERIMENTALCM383 injection and matched placebo, intravenous injection
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males, voluntarily participate;
- and 80 years old (including boundary values);
- able to communicate well with the researchers and follow up the protocol requirements.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinan Central Hospital
Jinan, Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qing Wen
Jinan Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2024
First Posted
May 14, 2024
Study Start
May 28, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
November 8, 2024
Record last verified: 2024-05