Phase I Study GX-G3 in Healthy Subjects

NCT ID: NCT01951027

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-12-31

Brief Summary

pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.

Detailed Description

MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation.

The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

GX-G3 12.5 μg/kg or Placebo

Group Type: EXPERIMENTAL

GX-G3 12.5 μg/kg or Placebo

Intervention Type: DRUG

Single SC injection

Cohort 2

GX-G3 25 μg/kg or Placebo

Group Type: EXPERIMENTAL

GX-G3 25 μg/kg or Placebo

Intervention Type: DRUG

Single SC injection

Cohort 3

GX-G3 50 μg/kg or Placebo

Group Type: EXPERIMENTAL

GX-G3 50 μg/kg or Placebo

Intervention Type: DRUG

Single SC injection

Cohort 4

GX-G3 100 μg/kg or Placebo

Group Type: EXPERIMENTAL

GX-G3 100 μg/kg or Placebo

Intervention Type: DRUG

Single SC injection

Interventions

GX-G3 12.5 μg/kg or Placebo

Single SC injection

Intervention Type: DRUG

GX-G3 25 μg/kg or Placebo

Single SC injection

Intervention Type: DRUG

GX-G3 50 μg/kg or Placebo

Single SC injection

Intervention Type: DRUG

GX-G3 100 μg/kg or Placebo

Single SC injection

Intervention Type: DRUG

Other Intervention Names

GX-G3(G-CSF-hyFc); GX-G3(G-CSF-hyFc); GX-G3(G-CSF-hyFc); GX-G3(G-CSF-hyFc)

Eligibility Criteria

Inclusion Criteria

Subjects may be entered in the study only if they meet all of the following criteria:

1. Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);

2. Healthy male volunteers aged 20-45 years;

3. Have a body weight of 60-90 kg (inclusive), have a body mass index (BMI) equal to or greater than 19 and less than 27 kg/m2;

4. Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);

Exclusion Criteria

Subjects presenting with any of the following will not be entered in to the study:

1. Have a history of or current evidence of disease;

2. Have percent of white blood cell (WBC) or neutrophil > UNL;

3. Have count of platelet < 100,000/mm3;

4. Have the longest length of spleen > 16 cm measured by abdomen ultrasonography ;

5. Have MSSBP ≥ 140 mmHg or ≤ 90 mmHg and/or MSDBP ≥ 95 mmHg or ≤ 50 mmHg; (BP must be measured after resting for at least 3 minutes)

6. Have clinically significant arrhythmia by EKG/ECG;

7. Are positive for HBV, HCV, HIV;

8. Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator;

9. Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing;

10. Have participated in another clinical trial with investigational drugs within 8 weeks of screening period;

11. Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator;

12. Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments;

13. Have a history of G-CSF treatment;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sang-In Yang, Ph.D

Role: STUDY_DIRECTOR

Genexine, Inc, Clinical development Department

Jae Woo Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center

Locations

Chungnam National University Hospital

Jung-gu, Daejeon, South Korea

Countries

South Korea

Other Identifiers

GX-G3_HV_1

Identifier Type: -

Identifier Source: org_study_id