A 2-stage, Phase 1/2a Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat (Phase 2a)

Caliway Biopharmaceuticals Co., Ltd.1 site in 1 country43 target enrollmentFebruary 3, 2020

ConditionsSubcutaneous Fat

InterventionsCBL-514

DrugsCBL-514

Overview

Phase: Phase 2
Intervention: CBL-514
Conditions: Subcutaneous Fat
Sponsor: Caliway Biopharmaceuticals Co., Ltd.
Enrollment: 43
Locations: 1
Primary Endpoint: Change of abdominal subcutaneous fat volume
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The Phase 2a component of the study will be a randomized, open-label, parallel, and multiple dose study to further examine the safety and efficacy profile of 3 CBL-514 dose levels based on the results from Phase 1 of the study.

Registry

clinicaltrials.gov

Start Date

February 3, 2020

End Date

November 12, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Caliway Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male/female aged 18 years to 64 years old (at Screening), inclusive.
•Body mass index \>18.5 and \<35 kg/m2 and body weight ≥50 kg at Screening and Day
•Has WC between 80.0 cm and 110.0 cm at Screening and Day
•Subcutaneous fat thickness of at least 3.00 cm (30.0 mm) and up to 6.00 cm (60.0 mm) by pinch method (measured by calibrated caliper) surrounding the center of treatment area at Screening and Day
•Subject has stable body weight for at least 3 months before Screening and during the study.
•Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking habit) for at least 3 months before Screening and during the study.
•Voluntarily signs the Informed Consent Form 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.

Exclusion Criteria

•Female subject of childbearing potential who is not willing to commit to an acceptable contraceptive regimen with her partner from the time of Screening and throughout study participation until 12 weeks after the last study drug dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method. For details on contraception, refer section 6.
•Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (e.g., defined as at least 50 years with ≥12 months of amenorrhea with a follicle stimulating hormone \>40 IU/L) are considered to be of non-childbearing potential. Subjects who are not of childbearing potential are not required to use contraception.
•Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
•Subject has diabetes or glycated hemoglobin ≥6.5% (48 mmol/mol) or fasting blood sugar ≥7 mmol/L.
•Subject has a clinically significant cardiovascular disease and abnormal findings in ECG.
•Subject with active or prior history of malignancies (except for successfully treated basal cell carcinoma) within 5 years before Screening or being worked-up for a possible malignancy.
•Subject with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections or subjects with active HIV, hepatitis B, or hepatitis C infections at Screening:
•Active HIV infection: positive HIV Ag/Ab combo test;
•Active hepatitis B virus (HBV) infection: positive HBV surface antigen (HBsAg). Subjects with negative HBsAg but with positive HBV core antibody, with or without positive HBV surface antibody will also be excluded. However, subjects with negative HBsAg, negative HBV core antibody, and positive HBV surface antibody may be included.
•Active hepatitis C virus (HCV) infection: positive HCV antibody.

Arms & Interventions

CBL-514 180 mg, 1.2 mg/cm^2

CBL-514 will be administrated with the grid spacing of 2.5 cm\^2

Intervention: CBL-514

CBL-514 240 mg, 1.6 mg/cm^2

CBL-514 will be administrated with the grid spacing of 2.5 cm\^2

Intervention: CBL-514

CBL-514 300 mg, 2 mg/cm^2

CBL-514 will be administrated with the grid spacing of 2.5 cm\^2

Intervention: CBL-514

Outcomes

Primary Outcomes

Change of abdominal subcutaneous fat volume

Time Frame: Up to 8 weeks after last treatment

Change of abdominal subcutaneous fat volume as measured by ultrasound around the treated area compared to Baseline

Secondary Outcomes

Change of abdominal subcutaneous fat thickness(Up to 8 weeks after last treatment)
Incidence of treatment emergent adverse events (TEAEs)(Up to 8 weeks after last treatment)
Number of participants with clinically significant abnormalities in clinical laboratory values(Up to 4 weeks after last treatment)
Number of participants with clinically significant abnormalities in vital signs(Up to 8 weeks after last treatment)
Number of participants with clinically significant abnormalities in Electrocardiogram (ECG)(Up to 4 weeks after last treatment)
Number of participants with clinically significant abnormalities in physical examination(Up to 8 weeks after last treatment)
Number of participants with injection site reactions(Up to 8 weeks after last treatment)