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A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05234736•Caliway Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male/female aged 18 years to 64 years old (at Screening), inclusive.
•2. Body mass index (BMI) \>18.5 and \< 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
•3. 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.
•4. 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.

Exclusion Criteria

•1. 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.
•2. Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
•3. 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.
•4. Participant has a clinically significant cardiovascular disease and clinically significant abnormal findings in electrocardiogram (ECG).
•5. 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.
•6. 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:
•7. Participants with positive COVID-19 antigen test at Screening and Day 1.
•8. 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.
•9. 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.
•10. 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:
+13 more criteria

Locations (1)

DermResearch Inc

Austin, Texas, United States

Key Dates

Start Date

February 11, 2022

Primary Completion Date

June 9, 2022

Completion Date

June 9, 2022

Last Updated

July 15, 2022

Enrollment

ACTUAL participants

Conditions

Subcutaneous Fat

Interventions

CBL-514

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat

Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

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