Phase I Study GX-G3 in Healthy Subjects

Genexine

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GX-G3 12.5 μg/kg or Placebo; Drug: GX-G3 50 μg/kg or Placebo; Drug: GX-G3 100 μg/kg or Placebo; Drug: GX-G3 25 μg/kg or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951027

GX-G3_HV_1

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 4 patient groups

Cohort 1

Experimental group

Description:

GX-G3 12.5 μg/kg or Placebo

Treatment:

Drug: GX-G3 12.5 μg/kg or Placebo

Cohort 2

Experimental group

Description:

GX-G3 25 μg/kg or Placebo

Treatment:

Drug: GX-G3 25 μg/kg or Placebo

Cohort 3

Experimental group

Description:

GX-G3 50 μg/kg or Placebo

Treatment:

Drug: GX-G3 50 μg/kg or Placebo

Cohort 4

Experimental group

Description:

GX-G3 100 μg/kg or Placebo

Treatment:

Drug: GX-G3 100 μg/kg or Placebo