NCT05234736

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

A Phase 2 Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 2 study to evaluate the safety, tolerability, PK and metabolite profile of CBL-514 injection at the maximal use dosage. This Phase 2 study has an open-label and single course design. A total of 10 adult participants, composed of 5 females and 5 males, will be enrolled in a single cohort. Each participant will receive a single course of treatment with CBL-514 800 mg on the abdomen (administered as multiple subcutaneous injections) on Day 1 only.

Conditions

• Subcutaneous Fat

Interventions

Type	Name	Description
DRUG	CBL-514	CBL-514 800 mg (unit dose: 2.0 mg/cm\^2)

Timeline

• Start date: 2022-02-11
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2022-02-10
• Last updated: 2022-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study