Clinical trial NCT01951027: Phase I Study GX-G3 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Pharmacokinetics
Pharmacodynamics
DLT
Immunogenecity
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 53
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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;

Primary outcomes:
measure: DLT incidence and frequency after GX-G3 single S.C. injection
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse events incidence and frequency at each dose group after GX-G3 single injection
timeFrame: 6 weeks
measure: Pharmacokinetics parameters after GX-G3 single injection
timeFrame: 3 weeks
measure: Pharmacodynamics parameters after GX-G3 single injection
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Daejeon
Study officials:
affiliation: Genexine, Inc, Clinical development Department
name: Sang-In Yang, Ph.D
role: STUDY_DIRECTOR
affiliation: CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
name: Jae Woo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: