- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02532712
Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers
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
Panoramica dello studio
Stato
Condizioni
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
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
-
Seoul, Corea, Repubblica di
- Yonsei University Health system, Severance Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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:
|
Comparatore placebo: Single dose group-Group 1-Placebo
Single dose, 500mg of Placebo
|
Placebo with same shape and size
Altri nomi:
|
Sperimentale: Single dose group-Group 2-Experimental
Single dose, 1000mg of Study drug(EC-18)
|
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
|
Comparatore placebo: Single dose group-Group 2-Placebo
Single dose, 1000mg of Placebo
|
Placebo with same shape and size
Altri nomi:
|
Sperimentale: Single dose group-Group 3-Experimental
Single dose, 2000mg of Study drug (EC-18)
|
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
|
Comparatore placebo: Single dose group-Group 3-Placebo
Single dose, 2000mg of Placebo
|
Placebo with same shape and size
Altri nomi:
|
Sperimentale: Single dose group-Group 4-Experimental
Single dose, 4000mg of Study drug (EC-18)
|
EC-18 Soft-capsule (500mg/1 capsule)
Altri nomi:
|
Comparatore placebo: Single dose group-Group 4-Placebo
Single dose, 4000mg of Placebo
|
Placebo with same shape and size
Altri nomi:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
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)?
Descrizione del piano IPD
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 .
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