- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Daejeon
-
Jung-gu, Daejeon, Corée, République de, 301-721
- Chungnam National University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cohort 1
GX-G3 12.5 μg/kg or Placebo
|
Single SC injection
Autres noms:
|
|
Expérimental: Cohort 2
GX-G3 25 μg/kg or Placebo
|
Single SC injection
Autres noms:
|
|
Expérimental: Cohort 3
GX-G3 50 μg/kg or Placebo
|
Single SC injection
Autres noms:
|
|
Expérimental: Cohort 4
GX-G3 100 μg/kg or Placebo
|
Single SC injection
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
DLT incidence and frequency after GX-G3 single S.C. injection
Délai: 6 weeks
|
[DLT criteria: CTCAE V4.03]
|
6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adverse events incidence and frequency at each dose group after GX-G3 single injection
Délai: 6 weeks
|
6 weeks
|
|
|
Pharmacokinetics parameters after GX-G3 single injection
Délai: 3 weeks
|
AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life
|
3 weeks
|
|
Pharmacodynamics parameters after GX-G3 single injection
Délai: 3 weeks
|
Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count
|
3 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Sang-In Yang, Ph.D, Genexine, Inc, Clinical development Department
- Chercheur principal: Jae Woo Kim, M.D., CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GX-G3_HV_1
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