A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
20 oktober 2014 uppdaterad av: Eisai Co., Ltd.
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011.
A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups).
Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.
Studieöversikt
Detaljerad beskrivning
This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period.
Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects.
The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician.
Each subjects dosing interval will be at least a 30-minutes.
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Kanagawa
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Sagamihara, Kanagawa, Japan
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 44 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion criteria
- Non-smoking Japanese male subjects aged greater than or equal to 20 to less than 45 years
- BMI at screening is greater than or equal to 18.5 kg/m2 to less than 25.0 kg/m2
- Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period
Exclusion criteria
- Has been treated with biologic product(s) (except for immunoglobulin)
- Has received immunoglobulin or blood preparation within 6 months before the study treatment
- Has received inoculation within 4 weeks before the study treatment
- Has a history of autoimmune disease or immunodeficiency
- Has a history of clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
- Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans
- With gross hematuria, occult bleeding in urine of greater than or equal to 1+ and urine protein of greater than or equal to 1+, or either of greater than or equal to 2+ is found at screening
- Has a clinically significant vasculitis (e.g., mononeuritis multiplex)
- Known to be positive for human immunodeficiency virus antigen/antibody (HIV antigen/antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B core virus antibody (HBc antibody), hepatitis B virus (HBV) DNA, hepatitis C virus antibody (HCV antibody), human T cell lymphotropic virus type 1 antibody (HTVL-1 antibody), or syphilis serology test positive at screening.
- Known to be positive for tuberculosis test (T-spot.TB Test or QuantiFERON TB Gold Test) at screening.
- Treated with ethical drug (except for disinfectants, eye drops) within 4 weeks before the study treatment.
- Treated with non-prescription drug (except for disinfectants, eye drops) within 2 weeks before the study treatment.
- Has participated in another clinical trial and received an investigational drug or device within 16 weeks before the study treatment.
- Received blood transfusion within 1 year, 400 mL or more whole blood donation within 12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent donation within 2 weeks before the study treatment.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 1
Subcutaneous administration of E6011 50 mg
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Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
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Experimentell: 2
Subcutaneous administration of E6011 100 mg
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Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
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Experimentell: 3
Subcutaneous administration of E6011 200 mg
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Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
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Experimentell: 4
Subcutaneous administration of E6011 400 mg
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Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
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Placebo-jämförare: 5
Subcutaneous administration of placebo
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Subkutan administrering av placebo
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pharmacokinetics of E6011: Maximum Concentration (Cmax)
Tidsram: Up to 10 Weeks
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Up to 10 Weeks
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Pharmacokinetics of E6011: Time to attain Cmax (tmax)
Tidsram: Up to 10 Weeks
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Up to 10 Weeks
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Pharmacokinetics of E6011: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-t)
Tidsram: Up to 10 Weeks
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Up to 10 Weeks
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Pharmacokinetics of E6011: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time AUC(0-inf)
Tidsram: Up to 10 Weeks
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Up to 10 Weeks
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|
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Pharmacokinetics of E6011: Elimination half-life (t1/2)
Tidsram: Up to 10 Weeks
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Up to 10 Weeks
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|
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Pharmacokinetics of E6011: CL/F
Tidsram: Up to 10 Weeks
|
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-?).
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Up to 10 Weeks
|
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Pharmacokinetics of E6011: Apparent Volume of Distribution of Azacitidine (Vz/F)
Tidsram: Up to 10 Weeks
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Up to 10 Weeks
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Safety and Tolerability of E6011
Tidsram: Up to 10 Weeks
|
The safety will be assessed based on all adverse events (AEs), clinical laboratory test, vital signs, body weight, physical finding, administration site finding, electrocardiography and chest xray.
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Up to 10 Weeks
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2013
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 april 2014
Studieregistreringsdatum
Först inskickad
21 maj 2014
Först inskickad som uppfyllde QC-kriterierna
22 maj 2014
Första postat (Uppskatta)
23 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 oktober 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E6011-J081-002
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