Your session is about to expire
← Back to Search
Other
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 time points on day1 and day2
Awards & highlights
No Placebo-Only Group
Summary
This trial involves injecting a substance called CBL-514 into the abdomen of 10 adults to see if it is safe and how their bodies react. The study will help understand the safety and effects of these injections. Each participant will receive a single course of treatment.
Timeline
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2021 Phase 2 trial • 25 Patients • NCT04575467100%
Injection site erythema
100%
Injection site bruising
100%
Injection site pain
100%
Injection site swelling
100%
Injection site warmth
100%
Injection site discolouration
100%
Injection site induration
67%
Injection site pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBL-514 320 mg
CBL-514 480 mg
CBL-514 640 mg
CBL-514 800 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
540 Total Patients Enrolled
6 Trials studying Subcutaneous Fat
463 Patients Enrolled for Subcutaneous Fat
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
402 Total Patients Enrolled
3 Trials studying Subcutaneous Fat
355 Patients Enrolled for Subcutaneous Fat