A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes

Early Phase 1SuspendedNCT06845943

Helicore Biopharma, Inc.48 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity and Overweight

Interventions

HCR-188DRUG

Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

PlaceboDRUG

Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Investigative Site

Herston, Queensland, Australia