Single Ascending Dose Study of CM326 in Healthy Volunteers
A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers
1 other identifier
interventional
44
1 country
1
Brief Summary
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started Apr 2021
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
April 8, 2021
CompletedFirst Posted
Study publicly available on registry
April 13, 2021
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2021
CompletedApril 12, 2022
November 1, 2021
6 months
April 8, 2021
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Day 1 through Day 85
Secondary Outcomes (3)
Pharmacokinetics (PK) of CM326
Day 1 through Day 85
Pharmacodynamics of CM326
Day 1 through Day 85
Immunogenicity
Day 1 through Day 85
Study Arms (2)
CM326
EXPERIMENTALsubcutaneous injection
Placebo
PLACEBO COMPARATORsubcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult male participant,18 to 65 years of age, inclusive.
- Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
- History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
- Males must abstain from sex or use highly effective methods of birth control.
- Having given written informed consent prior to undertaking any study-related procedure.
You may not qualify if:
- Positive for HIV, or Hepatitis B, or C.
- Positive result on urine drug screen.
- Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
- With any condition that inappropriate for entry into this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PKUCare Luzhong Hospital
Zibo, Shandong, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Hou
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2021
First Posted
April 13, 2021
Study Start
April 13, 2021
Primary Completion
September 28, 2021
Study Completion
September 28, 2021
Last Updated
April 12, 2022
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share