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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 16, 2018
First Posted Date  ICMJE July 25, 2019
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE October 2, 2018
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
Adverse Event [ Time Frame: Day 30 ]
Incidence of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pharmacology
Intervention  ICMJE
  • Drug: HM15136
    10 mg/mL as protein in prefilled syringes
  • Drug: Placebo of HM15136
    Placebo in prefilled syringes
Study Arms  ICMJE
  • Experimental: HM15136
    Intervention: Drug: HM15136
  • Placebo Comparator: Placebo of HM15136
    Intervention: Drug: Placebo of HM15136
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2020
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jahoon Kang +82 2 410 9041 jhkang@hanmi.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04032782
Other Study ID Numbers  ICMJE HM-GCG-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanmi Pharmaceutical Company Limited
Study Sponsor  ICMJE Hanmi Pharmaceutical Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hanmi Pharmaceutical Company Limited
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP