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A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04032782
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:

This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects.

The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).


Condition or disease Intervention/treatment Phase
Pharmacology Drug: HM15136 Drug: Placebo of HM15136 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: HM15136 Drug: HM15136
10 mg/mL as protein in prefilled syringes

Placebo Comparator: Placebo of HM15136 Drug: Placebo of HM15136
Placebo in prefilled syringes




Primary Outcome Measures :
  1. Adverse Event [ Time Frame: Day 30 ]
    Incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg

Exclusion Criteria:

  • with personal or family history of hypercoagulability or thromboembolic disease
  • has had treatment with any incretin therapy
  • has FPG < 70 or > 110 mg/dL

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): NCT04032782


Contacts
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Contact: Jahoon Kang +82 2 410 9041 jhkang@hanmi.co.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Howard Lee, Prof.         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04032782     History of Changes
Other Study ID Numbers: HM-GCG-101
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No