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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van
- Yonsei University Health System, Severance Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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)
Andere namen:
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Placebo-vergelijker: Single dose group-Group 1-Placebo
Single dose, 500mg of Placebo
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Placebo with same shape and size
Andere namen:
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Experimenteel: Single dose group-Group 2-Experimental
Single dose, 1000mg of Study drug(EC-18)
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EC-18 Soft-capsule (500mg/1 capsule)
Andere namen:
|
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Placebo-vergelijker: Single dose group-Group 2-Placebo
Single dose, 1000mg of Placebo
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Placebo with same shape and size
Andere namen:
|
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Experimenteel: Single dose group-Group 3-Experimental
Single dose, 2000mg of Study drug (EC-18)
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EC-18 Soft-capsule (500mg/1 capsule)
Andere namen:
|
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Placebo-vergelijker: Single dose group-Group 3-Placebo
Single dose, 2000mg of Placebo
|
Placebo with same shape and size
Andere namen:
|
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Experimenteel: Single dose group-Group 4-Experimental
Single dose, 4000mg of Study drug (EC-18)
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EC-18 Soft-capsule (500mg/1 capsule)
Andere namen:
|
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Placebo-vergelijker: Single dose group-Group 4-Placebo
Single dose, 4000mg of Placebo
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Placebo with same shape and size
Andere namen:
|
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Experimenteel: 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)
Andere namen:
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Placebo-vergelijker: Multiple dose group-Group 1-Placebo
Multiple dose, Placebo 500mg, Once daily, for 14 days
|
Placebo with same shape and size
Andere namen:
|
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Experimenteel: 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)
Andere namen:
|
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Placebo-vergelijker: Multiple dose group-Group 2-Placebo
Multiple dose, Placebo 1000mg, Once daily, for 14 days
|
Placebo with same shape and size
Andere namen:
|
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Experimenteel: 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)
Andere namen:
|
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Placebo-vergelijker: Multiple dose group-Group 3-Placebo
Multiple dose, Placebo 2000mg, Once daily, for 14 days
|
Placebo with same shape and size
Andere namen:
|
|
Experimenteel: 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)
Andere namen:
|
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Placebo-vergelijker: Multiple dose group-Group 4-Placebo
Multiple dose, Placebo 4000mg, Once daily, for 14 days
|
Placebo with same shape and size
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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No. and severity of Adverse event as a Measure of Safety and Tolerability
Tijdsspanne: From date of D-1 until Follow-up visit: up to 30 days
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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
Tijdsspanne: From date of screening until Follow-up visit: up to 60 days
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From date of screening until Follow-up visit: up to 60 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
Tijdsspanne: [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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[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)
Tijdsspanne: [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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[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: AUClast (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Tijdsspanne: [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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[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: AUCinf (Area under the plasma concentration-time curve from time zero extrapolated to the infinite time)
Tijdsspanne: [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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[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)
Tijdsspanne: [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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[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)
Tijdsspanne: [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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[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)
Tijdsspanne: [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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[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)
Tijdsspanne: [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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[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)
Tijdsspanne: [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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[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
Tijdsspanne: [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: t1/2 (half-life)
Tijdsspanne: [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: AUCτ (Area under the plasma concentration-time curve from time zero to time t)
Tijdsspanne: [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: AUCinf (Area under the plasma concentration-time curve from time zero to infinity)
Tijdsspanne: [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: Cmax (Maximum (peak) plasma drug concentration)
Tijdsspanne: [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: Tmax (Time to reach maximum (peak) plasma concentration following drug
Tijdsspanne: [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: CL/F (Apparent total clearance of the drug from plasma after oral administration)
Tijdsspanne: [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: Accumulation index
Tijdsspanne: [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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EC-18-101
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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