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

NCT ID: NCT02146625

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Dose level 1 of CJ-40002

* Single dose
* 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)

Group Type EXPERIMENTAL

CJ-40002

Intervention Type DRUG

Dose level 2 of CJ-40002

* Single dose
* 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)

Group Type EXPERIMENTAL

CJ-40002

Intervention Type DRUG

Dose level 3 of CJ-40002

* Single dose
* 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)

Group Type EXPERIMENTAL

CJ-40002

Intervention Type DRUG

Dose level 4 of CJ-40002

* Single dose
* 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)

Group Type EXPERIMENTAL

CJ-40002

Intervention Type DRUG

Dose level 5 of CJ-40002

* Single dose
* 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2)

Group Type EXPERIMENTAL

CJ-40002

Intervention Type DRUG

Interventions

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CJ-40002

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Soo Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University College of Medicine, Seoul, Korea

Other Identifiers

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CJ_HGH_101

Identifier Type: -

Identifier Source: org_study_id