A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211

April 27, 2018 updated by: Hanmi Pharmaceutical Company Limited

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211 in Healthy Obese Subjects

Single ascending dose of HM15211 in healthy obese subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Study Type

Interventional

Enrollment (Anticipated)

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 Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Hanmi Investigative Site
        • Contact:
          • Hanmi Pharmaceuticals
          • Phone Number: +82-2-410-9114
        • Contact:
          • Phone Number: +82-2-410-9114

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

  • Participation in an investigational study within 30 days prior to dosing

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: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
HM15211 or Placebo (single dose, subcutaneous injection)
Biological: HM15211 or Placebo
Long-acting tri-agonist
EXPERIMENTAL: Cohort 2
HM15211 or Placebo (single dose, subcutaneous injection)
Biological: HM15211 or Placebo
Long-acting tri-agonist
EXPERIMENTAL: Cohort 3
HM15211 or Placebo (single dose, subcutaneous injection)
Biological: HM15211 or Placebo
Long-acting tri-agonist
EXPERIMENTAL: Cohort 4
HM15211 or Placebo (single dose, subcutaneous injection)
Biological: HM15211 or Placebo
Long-acting tri-agonist
EXPERIMENTAL: Cohort 5
HM15211 or Placebo (single dose, subcutaneous injection)
Biological: HM15211 or Placebo
Long-acting tri-agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: 1 month
An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products
1 month

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

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 (ACTUAL)

April 4, 2018

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HM-TRIA-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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