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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

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

Condition or disease Intervention/treatment Phase
Pharmacology Drug: HM15912 or Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 HM15912 in Healthy Korean Subjects
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: HM15912 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


Placebo Comparator: Placebo 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





Primary Outcome Measures :
  1. 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 ]


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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:

  • 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

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04076293     History of Changes
Other Study ID Numbers: HM-GLP2-101
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No