Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers

25 gennaio 2016 aggiornato da: Enzychem Lifesciences Corporation

A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male Volunteers

This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of action of improving neutropenia by promoting neutrophil production from hematopoietic stem cells and at the same time, efficiently controlling STAT6/Complement 3(C3), suggesting its potential to be developed as an orally administered new drug for treatment of neutropenia resulting from decreased neutrophils caused by administration of an anticancer agent.

This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

64

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Seoul, Corea, Repubblica di
        • Yonsei University Health system, Severance Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 19 anni a 45 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
  • Body weight ≥ 50 kg, and calculated BMI in the range of 18.5 kg/m2 ≤ BMI < 25.0 kg/m2 ☞ BMI(body mass index) = Body weight (kg)/[height (m)]2
  • No inherited or chronic disease and pathologic symptoms or findings from internal examinations
  • Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug
  • Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial
  • Consent to practice medically acceptable contraception during the trial

Exclusion Criteria:

  • Hypersensitivity to a drug containing an ingredient of the investigational product (EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity
  • Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records
  • Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records
  • Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history
  • (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON® -TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis
  • Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Single dose group-Group 1-Experimental
Single dose, 500mg of Study drug(EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Single dose group-Group 1-Placebo
Single dose, 500mg of Placebo
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Single dose group-Group 2-Experimental
Single dose, 1000mg of Study drug(EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Single dose group-Group 2-Placebo
Single dose, 1000mg of Placebo
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Single dose group-Group 3-Experimental
Single dose, 2000mg of Study drug (EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Single dose group-Group 3-Placebo
Single dose, 2000mg of Placebo
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Single dose group-Group 4-Experimental
Single dose, 4000mg of Study drug (EC-18)
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Single dose group-Group 4-Placebo
Single dose, 4000mg of Placebo
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Multiple dose group-Group 1-Experimental
Multiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Multiple dose group-Group 1-Placebo
Multiple dose, Placebo 500mg, Once daily, for 14 days
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Multiple dose group-Group 2-Experimental
Multiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Multiple dose group-Group 2-Placebo
Multiple dose, Placebo 1000mg, Once daily, for 14 days
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Multiple dose group-Group 3-Experimental
Multiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Multiple dose group-Group 3-Placebo
Multiple dose, Placebo 2000mg, Once daily, for 14 days
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)
Sperimentale: Multiple dose group-Group 4-Experimental
Multiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
  • EC18 Capsula morbida
Comparatore placebo: Multiple dose group-Group 4-Placebo
Multiple dose, Placebo 4000mg, Once daily, for 14 days
Placebo with same shape and size
Altri nomi:
  • Placebo for EC-18 (Sofe-capsule)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
No. and severity of Adverse event as a Measure of Safety and Tolerability
Lasso di tempo: From date of D-1 until Follow-up visit: up to 30 days
From date of D-1 until Follow-up visit: up to 30 days
Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability
Lasso di tempo: From date of screening until Follow-up visit: up to 60 days
From date of screening until Follow-up visit: up to 60 days

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: Tmax (Time of maximum drug concentration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUClast (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUCinf (Area under the plasma concentration-time curve from time zero extrapolated to the infinite time)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: t1/2 (Half-life)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax,ss (Maximum (peak) steady-state plasma drug concentration during a dosage interval)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmin,ss (Minimum steady-state plasma drug concentration during a dosage interval)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cavg,ss (Average steady-state plasma drug concentration during multiple-dose administration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Fluctuation
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: t1/2 (half-life)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCτ (Area under the plasma concentration-time curve from time zero to time t)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: AUCinf (Area under the plasma concentration-time curve from time zero to infinity)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax (Maximum (peak) plasma drug concentration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Tmax (Time to reach maximum (peak) plasma concentration following drug
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following multiple oral doses: Accumulation index
Lasso di tempo: [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 16, 24, 36, 48 hours post dose

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2015

Completamento primario (Effettivo)

1 dicembre 2015

Completamento dello studio (Effettivo)

1 dicembre 2015

Date di iscrizione allo studio

Primo inviato

4 agosto 2015

Primo inviato che soddisfa i criteri di controllo qualità

23 agosto 2015

Primo Inserito (Stima)

26 agosto 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

27 gennaio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 gennaio 2016

Ultimo verificato

1 gennaio 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • EC-18-101

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

I will update the status when it is decided.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su EC-18

3
Sottoscrivi