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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HCR-188 in Overweight or Obese Volunteers
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Investigative Site
Herston, Queensland, Australia
Start Date
March 4, 2025
Primary Completion Date
October 22, 2025
Completion Date
December 1, 2027
Last Updated
November 26, 2025
48
ESTIMATED participants
HCR-188
DRUG
Placebo
DRUG
Lead Sponsor
Helicore Biopharma, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06976307