Phase I Study GX-G3 in Healthy Subjects (GX-G3)

A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GX-G3 12.5 μg/kg or Placebo; Drug: GX-G3 25 μg/kg or Placebo; Drug: GX-G3 50 μg/kg or Placebo; Drug: GX-G3 100 μg/kg or Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon
    • Jung-gu, Daejeon, Korea, Republic of, 301-721
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; GX-G3 12.5 μg/kg or Placebo	Drug: GX-G3 12.5 μg/kg or Placebo; Single SC injection; Other Names: GX-G3(G-CSF-hyFc)
Experimental: Cohort 2; GX-G3 25 μg/kg or Placebo	Drug: GX-G3 25 μg/kg or Placebo; Single SC injection; Other Names: GX-G3(G-CSF-hyFc)
Experimental: Cohort 3; GX-G3 50 μg/kg or Placebo	Drug: GX-G3 50 μg/kg or Placebo; Single SC injection; Other Names: GX-G3(G-CSF-hyFc)
Experimental: Cohort 4; GX-G3 100 μg/kg or Placebo	Drug: GX-G3 100 μg/kg or Placebo; Single SC injection; Other Names: GX-G3(G-CSF-hyFc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT incidence and frequency after GX-G3 single S.C. injection	[DLT criteria: CTCAE V4.03]; Hematologic type: grade 3 Hematologic N.O.S, grade 3 or 4 Leukocytosis; Non-Hematologic: grade 3 N.O.SN.O.S: not otherwise specifiedLeukocytosis: continued more than 5 days, grade 3(>100,000 cells/mm3), or grade 4(clinical manifestations of leucostasis; urgent intervention indicated)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events incidence and frequency at each dose group after GX-G3 single injection		6 weeks
Pharmacokinetics parameters after GX-G3 single injection	AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life	3 weeks
Pharmacodynamics parameters after GX-G3 single injection	Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count	3 weeks

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Study Director: Sang-In Yang, Ph.D, Genexine, Inc, Clinical development Department; Principal Investigator: Jae Woo Kim, M.D., CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Estimate): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Pharmacodynamics; Immunogenecity; DLT
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: GX-G3_HV_1