A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects

Hanmi Pharmaceutical Company Limited1 site in 1 country32 target enrollmentMarch 2010

ConditionsHealthy

InterventionsHM10560A Placebo

Overview

Phase: Phase 1
Intervention: HM10560A
Conditions: Healthy
Sponsor: Hanmi Pharmaceutical Company Limited
Enrollment: 32
Locations: 1
Primary Endpoint: Safety
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Study Design
- Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
- Four ascending dose cohorts.
- In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
Objectives
- The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.

Detailed Description

The secondary objectives of the study are as follows: * To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

August 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Hanmi Pharmaceutical Company Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study
•Body mass index of ≥19 and ≤26 Subject
•Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
•Able to participate in all procedure
•SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
•AST, ALT \<1.5 X UNL, CPK \< 2 X UNL
•Able to abstain from alcohol and smoke during study period
•Consented to contraception until 2 month after end of the study

Exclusion Criteria

•Acute infection history within 14 days
•Prior exposure or hypersensitivity to recombinant human growth hormone
•Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
•History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease
•psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment
•Caffeine, alcohol and smoke abuse
•History of hemophilia or anticoagulant treatment
•Revulsion and/or panic about syringe needle and hypersensitivity to subcutaneously administration
•History drug abuse or positive testing for amphetamine, barbiturate, cocaine, opiates, benzodiazepines
•Blood donation or significant blood loss within 60 days prior to Day