A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers

Overseen By Ivy Chen

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Anticoagulants, Antiplatelets, Steroids, Immunosuppressants

Disqualifiers: Pregnancy, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as those that affect blood clotting, certain steroids, and specific drugs that interact with liver enzymes. If you need to use these medications, you should stop at least 2 days before and until 1 day after the study dose.

What is the purpose of this trial?

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.

Research Team

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) >18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.

Participant has sufficient subcutaneous fat thickness of at least 3.00 cm (30.0 mm) measured by caliper skinfold method around treatment area at Screening and Day 1.

Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures, including food and drink restrictions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a single course of CBL-514 800 mg administered as multiple subcutaneous injections on the abdomen on Day 1

1 day

1 visit (in-person)

Pharmacokinetic Assessment

Evaluate pharmacokinetic parameters including Cmax, AUC, t1/2, CL/F, and Vz/F with 12 time points on Day 1 and Day 2

2 days

Multiple assessments over 2 days

Follow-up

Participants are monitored for treatment-related adverse events and clinically significant abnormalities in various health parameters

4 weeks

Up to 2 visits (in-person)

Treatment Details

Interventions

• CBL-514

Participant Groups

Group I: CBL-514 Experimental Treatment 1 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.

CBL-514 is already approved in European Union, United States for the following indications:

Approved in European Union as CBL-514 for:

• Dercum's disease

Approved in United States as CBL-514 for:

• Dercum's disease

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+