NCT02146625

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

May 19, 2014

Last Update Submit

December 28, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics: AUC, Cmax

    15 days

  • Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)

    29 days

Secondary Outcomes (3)

  • 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

Study Arms (5)

Dose level 1 of CJ-40002

EXPERIMENTAL

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

Drug: CJ-40002

Dose level 2 of CJ-40002

EXPERIMENTAL

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

Drug: CJ-40002

Dose level 3 of CJ-40002

EXPERIMENTAL

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

Drug: CJ-40002

Dose level 4 of CJ-40002

EXPERIMENTAL

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

Drug: CJ-40002

Dose level 5 of CJ-40002

EXPERIMENTAL

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

Drug: CJ-40002

Interventions

CJ-40002DRUG
Dose level 1 of CJ-40002Dose level 2 of CJ-40002Dose level 3 of CJ-40002Dose level 4 of CJ-40002Dose level 5 of CJ-40002

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Min Soo Park, MD, PhD

    Yonsei University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 26, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

December 29, 2016

Record last verified: 2016-12