Clinical trial NCT02146625: Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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
* 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

Primary outcomes:
measure: Pharmacokinetics: AUC, Cmax
timeFrame: 15 days
measure: Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
timeFrame: 29 days
Secondary outcomes:
measure: Pharmacokinetics: Tmax, T1/2, CL/F, Vd
timeFrame: 15 days
measure: Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP
timeFrame: 15 days
measure: Formation of anti-drug antibodies
timeFrame: 29 days
Other outcomes:
Locations:
Study officials:
affiliation: Yonsei University College of Medicine, Seoul, Korea
name: Min Soo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: