- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
-
-
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Seoul, Korejská republika
- Yonsei University Health System, Severance Hospital
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Single dose group-Group 1-Experimental
Single dose, 500mg of Study drug(EC-18)
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EC-18 Soft-capsule (500mg/1 capsule)
Ostatní jména:
|
|
Komparátor placeba: Single dose group-Group 1-Placebo
Single dose, 500mg of Placebo
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: Single dose group-Group 2-Experimental
Single dose, 1000mg of Study drug(EC-18)
|
EC-18 Soft-capsule (500mg/1 capsule)
Ostatní jména:
|
|
Komparátor placeba: Single dose group-Group 2-Placebo
Single dose, 1000mg of Placebo
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: Single dose group-Group 3-Experimental
Single dose, 2000mg of Study drug (EC-18)
|
EC-18 Soft-capsule (500mg/1 capsule)
Ostatní jména:
|
|
Komparátor placeba: Single dose group-Group 3-Placebo
Single dose, 2000mg of Placebo
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: Single dose group-Group 4-Experimental
Single dose, 4000mg of Study drug (EC-18)
|
EC-18 Soft-capsule (500mg/1 capsule)
Ostatní jména:
|
|
Komparátor placeba: Single dose group-Group 4-Placebo
Single dose, 4000mg of Placebo
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: 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)
Ostatní jména:
|
|
Komparátor placeba: Multiple dose group-Group 1-Placebo
Multiple dose, Placebo 500mg, Once daily, for 14 days
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: 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)
Ostatní jména:
|
|
Komparátor placeba: Multiple dose group-Group 2-Placebo
Multiple dose, Placebo 1000mg, Once daily, for 14 days
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: 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)
Ostatní jména:
|
|
Komparátor placeba: Multiple dose group-Group 3-Placebo
Multiple dose, Placebo 2000mg, Once daily, for 14 days
|
Placebo with same shape and size
Ostatní jména:
|
|
Experimentální: 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)
Ostatní jména:
|
|
Komparátor placeba: Multiple dose group-Group 4-Placebo
Multiple dose, Placebo 4000mg, Once daily, for 14 days
|
Placebo with same shape and size
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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No. and severity of Adverse event as a Measure of Safety and Tolerability
Časové okno: 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
|
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Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability
Časové okno: From date of screening until Follow-up visit: up to 60 days
|
From date of screening until Follow-up visit: up to 60 days
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following single oral dose: Tmax (Time of maximum drug concentration)
Časové okno: [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)
Časové okno: [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)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following single oral dose: t1/2 (Half-life)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following single oral dose: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmax,ss (Maximum (peak) steady-state plasma drug concentration during a dosage interval)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following multiple oral doses: Cmin,ss (Minimum steady-state plasma drug concentration during a dosage interval)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following multiple oral doses: Cavg,ss (Average steady-state plasma drug concentration during multiple-dose administration)
Časové okno: [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
|
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Pharmacokinetic parameters of EC-18 following multiple oral doses: Fluctuation
Časové okno: [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)
Časové okno: [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)
Časové okno: [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)
Časové okno: [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)
Časové okno: [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
Časové okno: [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)
Časové okno: [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
Časové okno: [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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EC-18-101
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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