Obesity and Overweight
Conditions
Brief summary
This is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of single and multiple doses of HCR-188 administered as subcutaneous injection(s).
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in overweight or obese volunteers without type 2 diabetes mellitus. Up to 5 SAD cohorts and up to 5 MAD cohorts may be enrolled. Multiple dosing regimens are planned to be evaluated in the MAD portion of the study. The duration of the study will be approximately 20 weeks per each participant completing the entire study.
Interventions
DRUGHCR-188
Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
DRUGPlacebo
Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
Sponsors
Helicore Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) of 27 to 40 kg/m2, inclusive * Except for overweight or obese, otherwise healthy as determined by the Investigator * Stable body weight, defined as a \< 5 kg change during the 8 weeks prior to screening * Females of childbearing potential must agree to use highly effective methods of contraception during the participation in the study * Males must be surgically sterile, abstinent, or must agree to use highly effective methods of contraception during participation in the study
Exclusion criteria
* History of or active cardiovascular (CV) disease * History of active pulmonary diseases * History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening * History of malignancy in the past 12 months or active malignancy * History of bariatric surgery or use of gastric balloons * History of diabetes mellitus Type 1 or 2 * History of chronic liver disease * Pregnant or breastfeeding, or a positive pregnancy test at Screening * Treatment with medications that may cause significant weight gain or weight loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events | From the first dose and for up to 20 weeks | Percentage of participants with treatment-emergent adverse events |
| Treatment-emergent adverse events resulting in treatment discontinuation | From the first dose and for up to 20 weeks | Percentage of participants with treatment-emergent adverse events resulting in treatment discontinuation |
| Clinically significant laboratory values | From the first dose and for up to 20 weeks | Percentage of participants with clinically significant laboratory values, as assessed by laboratory-based adverse events |
| Clinically significant vital signs | From the first dose and for up to 20 weeks | Percentage of participants with clinically significant vital signs (blood pressure, heart rate, respiratory rate, temperature), as assessed by vital signs-related adverse events |
| QT interval on ECG | From the first dose and for up to 20 weeks | Percentage of participants with an increase from baseline in the QTcF by \> 60 milliseconds |
Countries
Australia
Outcome results
None listed