← Back to Search

Other

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 time points on day1 and day2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 time points on day1 and day2 for reporting.

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 more
Secondary 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 more

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
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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025