Multiple Ascending Dose Study of CM338 in Healthy Volunteers
A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects
1 other identifier
interventional
48
1 country
1
Brief Summary
This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2022
Shorter than P25 for phase_1
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
May 7, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2022
CompletedOctober 15, 2024
October 1, 2024
5 months
May 7, 2022
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events (AEs).
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Up to Week 12.
Study Arms (5)
CM338 75 mg, subcutaneous injection
EXPERIMENTALQquaque week
CM338 150 mg, subcutaneous injection
EXPERIMENTALQquaque week
CM338 300 mg, subcutaneous injection
EXPERIMENTALQquaque week
CM338 300 mg, intravenous infusion
EXPERIMENTALQquaque week
Placebo
PLACEBO COMPARATORplacebo
Interventions
A humanized monoclonal antibody.
Eligibility Criteria
You may qualify if:
- Healthy male volunteers, aged ≥18 and ≤65 years.
- Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
- All clinical laboratory examination are normal, or abnormal without clinical significance.
You may not qualify if:
- Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
- Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
- Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
- Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PKUCare Luzhong Hospital
Zibo, China
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 7, 2022
First Posted
May 12, 2022
Study Start
May 24, 2022
Primary Completion
November 4, 2022
Study Completion
November 4, 2022
Last Updated
October 15, 2024
Record last verified: 2024-10