- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01951027
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Daejeon
-
Jung-gu, Daejeon, Korea, Republikken, 301-721
- Chungnam National University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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);
Exclusion Criteria:
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;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort 1
GX-G3 12.5 μg/kg or Placebo
|
Single SC injection
Andre navn:
|
|
Eksperimentell: Cohort 2
GX-G3 25 μg/kg or Placebo
|
Single SC injection
Andre navn:
|
|
Eksperimentell: Cohort 3
GX-G3 50 μg/kg or Placebo
|
Single SC injection
Andre navn:
|
|
Eksperimentell: Cohort 4
GX-G3 100 μg/kg or Placebo
|
Single SC injection
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
DLT incidence and frequency after GX-G3 single S.C. injection
Tidsramme: 6 weeks
|
[DLT criteria: CTCAE V4.03]
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events incidence and frequency at each dose group after GX-G3 single injection
Tidsramme: 6 weeks
|
6 weeks
|
|
|
Pharmacokinetics parameters after GX-G3 single injection
Tidsramme: 3 weeks
|
AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life
|
3 weeks
|
|
Pharmacodynamics parameters after GX-G3 single injection
Tidsramme: 3 weeks
|
Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count
|
3 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Sang-In Yang, Ph.D, Genexine, Inc, Clinical development Department
- Hovedetterforsker: Jae Woo Kim, M.D., CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GX-G3_HV_1
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