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Trial record 1 of 1 for:    NCT03374241
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A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211

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ClinicalTrials.gov Identifier: NCT03374241
Recruitment Status : Unknown
Verified April 2018 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : December 15, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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Brief Summary:
Single ascending dose of HM15211 in healthy obese subjects.

Condition or disease Intervention/treatment Phase
Obesity Biological: HM15211 or Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211 in Healthy Obese Subjects
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Participation in an investigational study within 30 days prior to dosing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374241


Locations
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United States, California
Hanmi Investigative Site Recruiting
Chula Vista, California, United States, 91911
Contact: Hanmi Pharmaceuticals    +82-2-410-9114      
Contact    +82-2-410-9114      
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Study Director: Hanmi Pharmaceuticals Hanmi Pharmaceuticals
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03374241    
Other Study ID Numbers: HM-TRIA-101
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No