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

HanAll Biopharma

Status and phase: Completed; Phase 1

Conditions: Growth Hormone Deficiency

Treatments: Drug: Placebo; Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440686

HGR10I_1

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups

HL-032 30mg

Experimental group

Description:

A single dose 30mg administered orally

Treatment:

Drug: Placebo

Drug: Somatropin

HL-032 60mg

Experimental group

Description:

A single dose 60mg administered orally

Treatment:

Drug: Placebo

Drug: Somatropin

HL-032 120mg

Experimental group

Description:

A single dose 120mg administered orally

Treatment:

Drug: Placebo

Drug: Somatropin