A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcu… (NCT04575467) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
Australia25 participantsStarted 2020-12-09
Plain-language summary
The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The primary objectives are to evaluate the safety and tolerability of injection lipolysis with CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Body mass index (BMI) \>18.5 and \<32 kg/m2 and body weight ≥50 kg at Screening and Day 1.
✓. Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of treatment area at Screening and Day 1.
✓. Subject has stable body weight (identified as ≤ 5% weight change) 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 (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
✕. 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 investigational product (IP) dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
✕. Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
✕. Subject has fasting hemoglobin A1c (HbA1c) ≥ 9%, delayed would healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
What they're measuring
1
Number of Treatment Emergent Adverse Events
Timeframe: Up to 4 weeks after treatment
2
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Timeframe: Up to 4 weeks after treatment
3
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Timeframe: Up to 4 weeks after treatment
4
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Timeframe: Up to 4 weeks after treatment
5
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Timeframe: Up to 4 weeks after treatment
6
Number of Participants With Injection Site Reactions
. Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
✕. 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.
✕. 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.
✕. 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.
✕. 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: