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

A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01440686

Acronym

HL-032

Enrollment

Registered

2011-09-26

Start date

2011-09-30

Completion date

2012-01-31

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Keywords

Pharmacokinetics, Pharmacodynamics, Safety, Male

Brief summary

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

Interventions

DRUGSomatropin

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

DRUGPlacebo

Tablets, oral administrations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the serum hGH(human growth hormone)concentration-time curve	From 0 to the time of the last quantifiable concentration over a 32-hour sampling period
Maximum observed serum hGH concentration	Over a 32-hour sampling period

Secondary

Measure	Time frame
Area under the effect(IGF-1, IGFBP-3, NEFA)curve	From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period
Maximum IGF-1, IGFBP-3, NEFA effect	Over a 32-hour sampling period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026