A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers

NCT04699669 | Completed Phase 1

• 1 other identifier: CBL-16001(Phase 1)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (6)

• Incidence of treatment emergent adverse events (TEAEs)

  Number of participants experiencing TEAEs and number of individual TEAEs among treatment groups by severity and relationship to investigational product (IP)

  Up to 4 weeks after treatment

• Number of participants with clinically significant abnormalities in clinical laboratory values

  Clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis testinjection site reactions.

  Up to 2 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 2 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 2 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 2 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 2 weeks after treatment

Secondary Outcomes (5)

• Assess maximum concentration of CBL-514 in plasma (Cmax)

  Up to 24 hours after treatment

• Assess time to Cmax of CBL-514 in plasma (tmax)

  Up to 24 hours after treatment

• Assess area under the concentration-time curve of CBL-514 in plasma (AUC)

  Up to 24 hours after treatment

• Assess terminal rate constant and half-life of CBL-514 in plasma (λz and t1/2)

  Up to 24 hours after treatment

• Assess apparent clearance and volume of distribution of CBL-514 in plasma (CL/F and Vz/F).

  Up to 24 hours after treatment

Study Arms (9)

Cohort 1: CBL-514 2 mg, 0.5 mg/cm^2

OTHER

Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2

Drug: CBL-514, placebo

Cohort 2: CBL-514 10 mg, 0.5 mg/cm^2

OTHER

Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2

Drug: CBL-514, placebo

Cohort 3: CBL-514 20 mg, 0.5 mg/cm^2

OTHER

Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2

Drug: CBL-514, placebo

Cohort 4: CBL-514 40 mg, 1.0 mg/cm^2

OTHER

Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2

Drug: CBL-514, placebo

Cohort 5: CBL-514 40 mg, 2 mg/cm^2

OTHER

Individual placebo control. CBL-514 will be administrated with the grid spacing of 2 cm\^2

Drug: CBL-514, placebo

Cohort 6: CBL-514 80 mg, 2 mg/cm^2

EXPERIMENTAL

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

Drug: CBL-514

Cohort 7: CBL-514 160 mg, 2 mg/cm^2

EXPERIMENTAL

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

Drug: CBL-514

Cohort 8: CBL-514 240 mg, 2 mg/cm^2

EXPERIMENTAL

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

Drug: CBL-514

Cohort 9: CBL-514 320 mg, 2 mg/cm^2

EXPERIMENTAL

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

Drug: CBL-514

Interventions

CBL-514, placebo DRUG

One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume. Which side of the abdominal region to receive CBL-514 or placebo would be randomized. No PK samples will be collected in this cohort.

Cohort 1: CBL-514 2 mg, 0.5 mg/cm^2; Cohort 2: CBL-514 10 mg, 0.5 mg/cm^2

CBL-514 DRUG

Both sides of the abdominal region will receive CBL-514.

Cohort 6: CBL-514 80 mg, 2 mg/cm^2; Cohort 7: CBL-514 160 mg, 2 mg/cm^2; Cohort 8: CBL-514 240 mg, 2 mg/cm^2; Cohort 9: CBL-514 320 mg, 2 mg/cm^2

Eligibility Criteria

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

You may qualify if:

• 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 1.
• Has MWC ≥80.0 cm at Screening and Day 1.
• 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 1.
• 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.

You may not qualify if:

• 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.
• Subject has abnormal skin or local skin conditions, 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 abdominal wall in the area to be treated,
• Skin or superficial tissue that does not lie flat on its own when the subject is in the supine position,
• Sensory loss or dysesthesia in the area to be treated,

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Investigational site

Melbourne, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 7, 2021
• Study Start: November 27, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)