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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

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

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

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 more

Secondary 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 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT04575467

100%

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%

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

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