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 1)

Caliway Biopharmaceuticals Co., Ltd.1 site in 1 country40 target enrollmentNovember 27, 2018

ConditionsSubcutaneous Fat

InterventionsCBL-514, placebo CBL-514

DrugsCBL-514, placebo CBL-514

Overview

Phase: Phase 1
Intervention: CBL-514, placebo
Conditions: Subcutaneous Fat
Sponsor: Caliway Biopharmaceuticals Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Incidence of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The Phase 1 component of the study is a double-blind, placebo-controlled, single ascending dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD part will involve 9 proposed dosing cohorts.

Detailed Description

The Phase 1 part of the study was a first-in-human, single ascending dose, double-blind, randomized (except Cohorts 6 to 9 \[open-label\]) study in healthy subjects to evaluate the safety, tolerability and PK of CBL-514, and to determine the dose levels to be used for the Phase 2a part of the study.

Registry

clinicaltrials.gov

Start Date

November 27, 2018

End Date

August 20, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Caliway Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A subject can participate in the study only if all the following criteria are met:
•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 MWC ≥80.0 cm at Screening and Day
•Subcutaneous fat thickness of at least 3.00 cm (30.0 mm) by pinch method (measured by calibrated caliper) surrounding the navel at Screening and Day
•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

•A subject who meets any of the following criteria will not be eligible to enter the study:
•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. 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 nonchildbearing 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 cardiovascular disease, or shows clinically significant abnormal findings in ECG at Screening.
•Subject with active or prior history of malignancies (except for successfully treated non-invasive basal cell carcinoma) 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.