Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects

A Dose-block Randomized, Single-blind, Placebo-controlled, Single-dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02146625

Acronym

hGH

Enrollment

Registered

2014-05-26

Start date

2014-11-30

Completion date

2015-09-30

Last updated

2016-12-29

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

Conditions

Healthy

Brief summary

The objectives of this study are: * To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers. * To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers. * To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers. * To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.

Interventions

DRUGCJ-40002

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers in the age between 19 and 45 years old (inclusive) * Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg * Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial

Exclusion criteria

* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition * History of allergy or sensitivity to any drug * Subject with the following clinically significant laboratory abnormalities: * AST or ALT \> 1.25 x Upper Limit Normal (ULN) * Total bilirubin \> 1.5 x Upper Limit Normal (ULN) * CPK \> 1.5 x Upper Limit Normal (ULN) * eGFR \< 60 mL/min/1.73 m2 * Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg * History of drug abuse * History of caffeine, alcohol, smoking abuse * Participation in any clinical investigation within 60days prior to study medication dosing * Subjects with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing * Positive test results for HBs Ab, HCV Ab, HIV test * Subjects considered as unsuitable based on medical judgement by investigators

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: AUC, Cmax	15 days
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)	29 days

Secondary

Measure	Time frame
Pharmacokinetics: Tmax, T1/2, CL/F, Vd	15 days
Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP	15 days
Formation of anti-drug antibodies	29 days

Outcome results

None listed

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