Phase I Study GX-G3 in Healthy Subjects

NCT01951027 | Completed Phase 1

• 1 other identifier: GX-G3_HV_1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Safety; Pharmacokinetics; Pharmacodynamics; DLT; Immunogenecity

Outcome Measures

Primary Outcomes (1)

• DLT incidence and frequency after GX-G3 single S.C. injection

  \[DLT criteria: CTCAE V4.03\] 1. Hematologic type: grade 3 Hematologic N.O.S, grade 3 or 4 Leukocytosis 2. Non-Hematologic: grade 3 N.O.S * N.O.S: not otherwise specified * Leukocytosis: continued more than 5 days, grade 3(\>100,000 cells/mm3), or grade 4(clinical manifestations of leucostasis; urgent intervention indicated)

  6 weeks

Secondary Outcomes (3)

• Adverse events incidence and frequency at each dose group after GX-G3 single injection

  6 weeks

• Pharmacokinetics parameters after GX-G3 single injection

  3 weeks

• Pharmacodynamics parameters after GX-G3 single injection

  3 weeks

Study Arms (4)

Cohort 1

EXPERIMENTAL

GX-G3 12.5 μg/kg or Placebo

Drug: GX-G3 12.5 μg/kg or Placebo

Cohort 2

EXPERIMENTAL

GX-G3 25 μg/kg or Placebo

Drug: GX-G3 25 μg/kg or Placebo

Cohort 3

EXPERIMENTAL

GX-G3 50 μg/kg or Placebo

Drug: GX-G3 50 μg/kg or Placebo

Cohort 4

EXPERIMENTAL

GX-G3 100 μg/kg or Placebo

Drug: GX-G3 100 μg/kg or Placebo

Interventions

GX-G3 12.5 μg/kg or Placebo DRUG

Single SC injection

Also known as: GX-G3(G-CSF-hyFc)

Cohort 1

GX-G3 25 μg/kg or Placebo DRUG

Single SC injection

Also known as: GX-G3(G-CSF-hyFc)

Cohort 2

GX-G3 50 μg/kg or Placebo DRUG

Single SC injection

Also known as: GX-G3(G-CSF-hyFc)

Cohort 3

GX-G3 100 μg/kg or Placebo DRUG

Single SC injection

Also known as: GX-G3(G-CSF-hyFc)

Cohort 4

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects may be entered in the study only if they meet all of the following criteria:
• Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);
• Healthy male volunteers aged 20-45 years;
• 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;
• Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);

You may not qualify if:

• Subjects presenting with any of the following will not be entered in to the study:
• Have a history of or current evidence of disease;
• Have percent of white blood cell (WBC) or neutrophil \> UNL;
• Have count of platelet \< 100,000/mm3;
• Have the longest length of spleen \> 16 cm measured by abdomen ultrasonography ;
• 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)
• Have clinically significant arrhythmia by EKG/ECG;
• Are positive for HBV, HCV, HIV;
• Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator;
• Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing;
• Have participated in another clinical trial with investigational drugs within 8 weeks of screening period;
• Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator;
• Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments;
• Have a history of G-CSF treatment;

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Chungnam National University Hospital

Jung-gu, Daejeon, 301-721, South Korea

Location

Study Officials

• Sang-In Yang, Ph.D

  Genexine, Inc, Clinical development Department

  STUDY DIRECTOR

• Jae Woo Kim, M.D.

  CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 26, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

KR (1)