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Trial record 1 of 1 for:    NCT04032782
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A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032782
Recruitment Status : Completed
First Posted : July 25, 2019
Last Update Posted : March 21, 2022
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)
Actual 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
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : August 29, 2019

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


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04032782    
Other Study ID Numbers: HM-GCG-101
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022

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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