A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)
NCT ID: NCT03374241
Last Updated: 2025-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2018-04-04
2018-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
HM15211 or Placebo (single dose, subcutaneous injection)
HM15211 or Placebo
Long-acting tri-agonist
Cohort 2
HM15211 or Placebo (single dose, subcutaneous injection)
HM15211 or Placebo
Long-acting tri-agonist
Cohort 3
HM15211 or Placebo (single dose, subcutaneous injection)
HM15211 or Placebo
Long-acting tri-agonist
Cohort 4
HM15211 or Placebo (single dose, subcutaneous injection)
HM15211 or Placebo
Long-acting tri-agonist
Cohort 5
HM15211 or Placebo (single dose, subcutaneous injection)
HM15211 or Placebo
Long-acting tri-agonist
Interventions
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HM15211 or Placebo
Long-acting tri-agonist
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hanmi Pharmaceuticals
Role: STUDY_DIRECTOR
Hanmi Pharmaceuticals
Locations
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Hanmi Investigative Site
Chula Vista, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HM-TRIA-101
Identifier Type: -
Identifier Source: org_study_id
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