Study to Compare and Evaluate the Safety and Pharmacokinetics After Subcutaneous Injection of HUC2-676 or HUC2-676-R in Healthy Adult Subjects

January 6, 2026 updated by: Huons Co., Ltd.

A Randomized, Open-label, Single Dose, Two-way, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics After Subcutaneous Injection of HUC2-676 or HUC2-676-R in Healthy Adult Subjects

The trial uses a randomized, open-label, single-dose administration per period, and a 2 x 2 crossover design where subjects receive both treatments sequentially with a washout.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adult volunteers aged 19 to 65 years, inclusive, at screening.
  • Subjects who have been fully informed of the details of this clinical trial, have fully understood the information, have voluntarily decided to participate, and have provided written informed consent to comply with all protocol requirements throughout the trial period.

Exclusion Criteria:

  • Subjects with a current or past clinically significant medical history of hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, or other disorders.
  • For females: Pregnant women (positive urine hCG) or nursing mothers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HUC2-676
Drug: HUC2-676
subcutaneous injection
Active Comparator: HUC2-676-R
Drug: HUC2-676-R
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax following single-dose administration
Time Frame: 0 through 72 hours post-dose
0 through 72 hours post-dose
AUC following single-dose administration
Time Frame: 0 through 72 hours post-dose
0 through 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huons Co., Ltd.

Investigators

  • Principal Investigator: Park, Chungbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

March 24, 2026

Study Completion (Estimated)

March 24, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUC2-676

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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