Study of CM326 Injection in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
1 other identifier
interventional
46
1 country
1
Brief Summary
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2023
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2023
CompletedNovember 8, 2024
March 1, 2023
7 months
January 27, 2023
November 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Emergency adverse events during treatment
By assessing the number and severity of adverse events during the study.
Up to week 12
Study Arms (4)
Group 1
EXPERIMENTALCM326 220 mg/2 mL or matched placebo, subcutaneous at low dose
Group 2
EXPERIMENTALCM326 220mg/2 mL or matched placebo, subcutaneous at medium dose
Group 3
EXPERIMENTALCM326 220mg/2mL or matched placebo, subcutaneous at high dose
Group 4
EXPERIMENTALCM326 220mg/2mL or matched placebo, subcutaneous at medium dose
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years and ≤ 65 years, healthy male.
- With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
- Subjects can communicate well with investigators and comply with protocol requirements.
You may not qualify if:
- Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
- Major surgery is planned during the study period.
- The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
- Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
- There are any reasons that the investigator believes will prevent the subject from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PKUCare Luzhong Hospital
Zibo, China
Related Publications (1)
Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4.
PMID: 40185989DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Hou
Peking University Care Luzhong Hospital
- PRINCIPAL INVESTIGATOR
Hong Wang
Peking University Care Luzhong Hospital
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
January 27, 2023
First Posted
February 8, 2023
Study Start
March 21, 2023
Primary Completion
October 4, 2023
Study Completion
October 4, 2023
Last Updated
November 8, 2024
Record last verified: 2023-03