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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CJ-40002

• Registration Number: NCT02146625
• Lead Sponsor: HK inno.N Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Study Start: 2014-11
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 2 of CJ-40002	CJ-40002	* Single dose * 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
Dose level 1 of CJ-40002	CJ-40002	* Single dose * 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
Dose level 3 of CJ-40002	CJ-40002	* Single dose * 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
Dose level 4 of CJ-40002	CJ-40002	* Single dose * 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)
Dose level 5 of CJ-40002	CJ-40002	* Single dose * 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)

Primary Outcome Measures

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

Secondary Outcome Measures

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