A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)

NCT04575467 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CBL-0202
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (6)

• Number of Treatment Emergent Adverse Events

  Number of treatment emergent adverse events (TEAEs)

  Up to 4 weeks after treatment

• Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values

  The clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test

  Up to 4 weeks after treatment

• Number of Participants With Clinically Significant Abnormalities in Vital Signs

  Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate

  Up to 4 weeks after treatment

• Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

  ECG parameters include heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval

  Up to 4 weeks after treatment

• Number of Participants With Clinically Significant Abnormalities in Physical Examination

  Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems

  Up to 4 weeks after treatment

• Number of Participants With Injection Site Reactions

  Injection site reactions include but not limited to redness, swelling, bruising, tenderness, itching, pain, warmth, discoloration and hardness

  Up to 4 weeks after treatment

Secondary Outcomes (2)

• Change in Subcutaneous Fat Thickness

  Up to 4 weeks after treatment

• Change in Subcutaneous Fat Volume

  Up to 4 weeks after treatment

Study Arms (4)

CBL-514 320 mg

EXPERIMENTAL

CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.

Drug: CBL-514

CBL-514 480 mg

EXPERIMENTAL

CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.

Drug: CBL-514

CBL-514 640 mg

EXPERIMENTAL

CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.

Drug: CBL-514

CBL-514 800 mg

EXPERIMENTAL

CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.

Drug: CBL-514

Interventions

CBL-514 DRUG

CBL-514 will be administered via injection into the subcutaneous adipose layer.

CBL-514 320 mg; CBL-514 480 mg; CBL-514 640 mg; CBL-514 800 mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (e.g., defined as at least 50 years with ≥12 months of amenorrhea with a follicle stimulating hormone (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.
• 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.
• 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:
• Skin manifestations of a systemic disease,
• Any abnormality of the skin or soft tissues of the area to be treated,
• Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to be treated,
• Skin folding on treatment area when the subject is in the supine position,
• Sensory loss or dysesthesia in the area to be treated,
• Evidence of any cause of enlargement in the area to be treated other than localized subcutaneous fat,

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Investigational Site

Melbourne, Victoria, Australia

Location

Results Point of Contact

• Title: Candra Chou
• Organization: Caliway Biopharmaceuticals Pty Ltd

candra.chou@caliway.com

886226971355

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: October 5, 2020
• Study Start: December 9, 2020
• Primary Completion: November 15, 2021
• Study Completion: December 8, 2021
• Last Updated: August 9, 2024
• Results First Posted: March 28, 2024

Record last verified: 2024-07

Locations

AU (1)