A Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL 514 Injectionon Thigh Subcutaneous Fat in healthy adults

Caliway Biopharmaceuticals Australia Pty Ltd0 sites18 target enrollmentNovember 3, 2020

ConditionsHealthy to overweight subjects with undesirable subcutaneous fat thickness in thighs Skin - Dermatological conditions Diet and Nutrition - Obesity

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Healthy to overweight subjects with undesirable subcutaneous fat thickness in thighs
Sponsor: Caliway Biopharmaceuticals Australia Pty Ltd
Enrollment: 18
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 3, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Caliway Biopharmaceuticals Australia Pty Ltd

Eligibility Criteria

Inclusion Criteria

•To be eligible for this study, a subject must meet all of the following inclusion criteria:
•1\.Male or female, aged 18 years to 64 years old (at Screening), inclusive.
•2\.Body mass index (BMI) \>18\.5 and \<32 kg/m2 and body weight great than or equal to 50 kg at Screening and Day 1\.
•3\.Subject has sufficient thigh subcutaneous fat thickness of at least 1\.50 cm and up to 5\.00 cm measured by ultrasound, surrounding the center of treatment area at Screening and Day 1\.
•4\.Subject has stable body weight (identified as smaller than or equal to 5% weight change) for at least 3 months before Screening and during the study.
•5\.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.
•6\.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.

Exclusion Criteria

•A subject who meets any of the following exclusion criteria must be excluded from the study:
•1\.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 90 days after the last IP 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 post\-menopausal (e.g., defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a FSH \>40 IU/L) are considered to be of non\-childbearing potential. Subjects who are not of childbearing potential are not required to use contraception.
•2\.Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
•3\.Subject has fasting hemoglobin A1c (HbA1c) great than or equal to 7%.
•4\.Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
•5\.Subject 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\.Subject with a history of human immunodeficiency virus (HIV)\-1, infection or subjects with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
•7\.Subjects with any hepatic medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
•8\.Subject 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: