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Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects

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ClinicalTrials.gov Identifier: NCT04076293
Recruitment Status : Not yet recruiting
First Posted : September 2, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE September 2, 2019
Last Update Posted Date September 2, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
Adverse event (AE) assessments, clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), physical examinations [ Time Frame: after single subcutaneous (SC) doses for 30 days ]
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 Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean 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 HM15912 in Healthy Korean Subjects
Brief Summary A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pharmacology
Intervention  ICMJE Drug: HM15912 or Placebo

The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). When necessary, one dosing cohort may be added or removed.

In this first-in-human (FiH) study, each cohort will be divided in 2 blocks in order to implement the sentinel dosing approach. Within each cohort, the first block will consist of 2 sentinel subjects

Study Arms  ICMJE
  • Experimental: HM15912
    Intervention: Drug: HM15912 or Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: HM15912 or Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
  • Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit
  • Female subjects must be non-pregnant and non-lactating and either surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or post-menopausal for ≥ 12 months. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at the Screening visit for amenorrheic female subjects ≤ 60 years of age.

Exclusion Criteria:

  • Subject with a history or presence of clinically significant active diseases of the gastrointestinal, cardiovascular (including a history of arrhythmia or any clinically significant conduction delays in the ECG), hepatic, pulmonary, neurological, renal, pancreatic, immunological, dermatological, endocrine, genitourinary or hematological system
  • Subject with a history or presence of skin rashes or dermatitis
  • Subject with a history or presence of any psychiatric disorder that, in the opinion of the Principal Investigator, might confound the results of the study or pose additional risk in administering the investigational product to the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04076293
Other Study ID Numbers  ICMJE HM-GLP2-101
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 August 2019

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