NCT02146625
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- CJ-40002
- Conditions
- Healthy
- Sponsor
- HK inno.N Corporation
- Enrollment
- 40
- Primary Endpoint
- Pharmacokinetics: AUC, Cmax
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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)
Intervention: CJ-40002
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)
Intervention: CJ-40002
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)
Intervention: CJ-40002
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)
Intervention: CJ-40002
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)
Intervention: CJ-40002
Outcomes
Primary Outcomes
Pharmacokinetics: AUC, Cmax
Time Frame: 15 days
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
Time Frame: 29 days
Secondary Outcomes
- 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)
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