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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2018-09-14

Brief Summary

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Single ascending dose of HM15211 in healthy obese subjects.

Detailed Description

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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

HM15211 or Placebo (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM15211 or Placebo

Intervention Type BIOLOGICAL

Long-acting tri-agonist

Cohort 2

HM15211 or Placebo (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM15211 or Placebo

Intervention Type BIOLOGICAL

Long-acting tri-agonist

Cohort 3

HM15211 or Placebo (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM15211 or Placebo

Intervention Type BIOLOGICAL

Long-acting tri-agonist

Cohort 4

HM15211 or Placebo (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM15211 or Placebo

Intervention Type BIOLOGICAL

Long-acting tri-agonist

Cohort 5

HM15211 or Placebo (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM15211 or Placebo

Intervention Type BIOLOGICAL

Long-acting tri-agonist

Interventions

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HM15211 or Placebo

Long-acting tri-agonist

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Participation in an investigational study within 30 days prior to dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HM-TRIA-101

Identifier Type: -

Identifier Source: org_study_id

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