Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

HanAll BioPharma Co., Ltd.40 enrolled

Overview

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Growth Hormone Deficiency

Interventions

SomatropinDRUG

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

PlaceboDRUG

Tablets, oral administrations

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects * Age(yr)between 19 and 50 * Signed written informed consent Exclusion Criteria: * Known hypersensitivity to Octreotide or hGH(human growth hormone) * History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer * Alcoholic, smokers or drug abusers * Other conditions which in the opinion of the investigator preclude enrollment into the study

Locations (1)

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Seoul, South Korea

Outcomes

Primary Outcomes

Area under the serum hGH(human growth hormone)concentration-time curve

Time frame: From 0 to the time of the last quantifiable concentration over a 32-hour sampling period

Maximum observed serum hGH concentration

Time frame: Over a 32-hour sampling period

Secondary Outcomes

Area under the effect(IGF-1, IGFBP-3, NEFA)curve

Time frame: From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period

Maximum IGF-1, IGFBP-3, NEFA effect

Time frame: Over a 32-hour sampling period

Data from ClinicalTrials.gov

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