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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ-40002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02146625

CJ_HGH_101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 5 patient groups

Dose level 1 of CJ-40002

Experimental group

Description:

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

Treatment:

Drug: CJ-40002

Dose level 2 of CJ-40002

Experimental group

Description:

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

Treatment:

Drug: CJ-40002

Dose level 3 of CJ-40002

Experimental group

Description:

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

Treatment:

Drug: CJ-40002

Dose level 4 of CJ-40002

Experimental group

Description:

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

Treatment:

Drug: CJ-40002

Dose level 5 of CJ-40002

Experimental group

Description:

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

Treatment:

Drug: CJ-40002