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

Part of paid clinical trials in Austin, Texas.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT05234736
Phase
PHASE2
Status
Completed

Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CBL-514 — DRUG
    CBL-514 800 mg (unit dose: 2.0 mg/cm\^2)

Study Details

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.

Key Dates

Start date
Feb 11, 2022
Status verified
May 2026
Primary completion
Jun 9, 2022
Completion
Jun 9, 2022

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514
    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.

Primary Outcome Measure

Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax) [ Time Frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
DermResearch IncAustinTexas78759-

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DermResearch Inc· Austin, TX

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