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

NCT05234736 | Completed Phase 2 FDA Drug

• 1 other identifier: CBL-0203
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (6)

• Assess maximum analyte concentration of CBL-514 in plasma (Cmax)

  To evaluate maximum analyte concentration of CBL-514 in plasma (Cmax) after single dose injection.

  12 time points on Day1 and Day2

• Assess time to Cmax of CBL-514 in plasma (tmax)

  To evaluate time to Cmax of CBL-514 in plasma (tmax) after single dose injection.

  12 time points on Day1 and Day2

• Assess area under the concentration-time curve of CBL-514 in plasma (AUC)

  To evaluate area under the concentration-time curve of CBL-514 in plasma (AUC) after single dose injection.

  12 time points on Day1 and Day2

• Assess elimination half-life of CBL-514 in plasma (t1/2)

  To evaluate elimination half-life of CBL-514 in plasma (t1/2) after single dose injection.

  12 time points on Day1 and Day2

• Assess apparent total plasma clearance of CBL-514 in plasma (CL/F).

  To evaluate apparent total plasma clearance of CBL-514 (CL/F) after single dose injection.

  12 time points on Day1 and Day2

• Assess apparent terminal volume of distribution of CBL-514 in plasma (Vz/F).

  To evaluate apparent terminal volume of distribution of CBL-514 in plasma (Vz/F) after single dose injection.

  12 time points on Day1 and Day2

Secondary Outcomes (7)

• Metabolites of CBL-514 in plasma

  12 time points on Day1 and Day2

• Number of participants with treatment-related adverse events (TEAEs) as assessed by CTCAE v5.0

  Up to 4 weeks after last treatment

• Number of participants with clinically significant abnormalities in anthropometric parameters

  On Screening Day and Day1

• Number of participants with clinically significant abnormalities in physical examination

  Up to 2 weeks after last treatment

• Number of participants with clinically significant abnormalities in clinical laboratory values

  Up to 2 weeks after last treatment

Study Arms (1)

CBL-514

EXPERIMENTAL

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.

Drug: CBL-514

Interventions

CBL-514 DRUG

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

CBL-514

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Women of childbearing potential (WOCBP) who are not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who are currently pregnant or lactating. Male participants who are not willing to commit to an acceptable contraceptive method. Female participants who are not WOCBP are not required to use contraception.
• Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
• Participant has hemoglobin A1c (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
• Participant has a clinically significant cardiovascular disease and clinically significant abnormal findings in electrocardiogram (ECG).
• Participant with active or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per Investigator's discretion.
• Participant with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections or participants with active HIV, hepatitis B, or hepatitis C infections at Screening:
• Participants with positive COVID-19 antigen test at Screening and Day 1.
• Participants with any hepatic medical condition that, in the opinion of the Investigator, would compromise the participant's ability to undergo study procedures and/or interfere with the assessment of the obtained data.
• Participants with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and faint or pass out at the sight of blood or a needle.
• Participant has abnormal skin or local skin conditions at the treatment area, which in the opinion of Investigator, is inappropriate to participate in the study, including but not limited to any of the following:
• Participant who has the following procedures:
• Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study,
• Liposuction to the region to be treated before Screening or during the study,
• Esthetic procedure e.g., cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study.
• Participant is undergoing chronic systemic steroid or immunosuppressive therapy.

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

DermResearch Inc

Austin, Texas, 78759, United States

Location

Study Officials

• Anne Sheu

  Caliway Biopharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 10, 2022
• Study Start: February 11, 2022
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

US (1)