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CBL-514 for Subcutaneous Fat
Phase 2
Waitlist Available
Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male/female aged 18 years to 64 years old (at Screening), inclusive.
Body mass index (BMI) >18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 time points on day1 and day2
Awards & highlights
Study Summary
This Phase 2 study will be an open-label and single course study to assess the safety, tolerability, PK and metabolite profile of CBL-514.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 time points on day1 and day2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 time points on day1 and day2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess apparent terminal volume of distribution of CBL-514 in plasma (Vz/F).
Assess apparent total plasma clearance of CBL-514 in plasma (CL/F).
Assess area under the concentration-time curve of CBL-514 in plasma (AUC)
+3 moreSecondary outcome measures
Metabolites of CBL-514 in plasma
Number of participants with clinically significant abnormalities in Electrocardiogram (ECG)
Number of participants with clinically significant abnormalities in anthropometric parameters
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CBL-514Experimental Treatment1 Intervention
All 10 participants enrolled in the study will receive a single course of treatment with CBL-514 800 mg (unit dose: 2.0 mg/cm^2) on the abdomen (administered as multiple subcutaneous injections) on Day 1 only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBL-514
2022
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
526 Total Patients Enrolled
6 Trials studying Subcutaneous Fat
449 Patients Enrolled for Subcutaneous Fat
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
389 Total Patients Enrolled
3 Trials studying Subcutaneous Fat
342 Patients Enrolled for Subcutaneous Fat
Frequently Asked Questions
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