A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
20. oktober 2014 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kanagawa
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Sagamihara, Kanagawa, Japan
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 44 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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 komparator: 5
Subcutaneous administration of placebo
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Subkutan administrering av placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacokinetics of E6011: Maximum Concentration (Cmax)
Tidsramme: Up to 10 Weeks
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Up to 10 Weeks
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Pharmacokinetics of E6011: Time to attain Cmax (tmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 10 Weeks
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Up to 10 Weeks
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Pharmacokinetics of E6011: Elimination half-life (t1/2)
Tidsramme: Up to 10 Weeks
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Up to 10 Weeks
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Pharmacokinetics of E6011: CL/F
Tidsramme: Up to 10 Weeks
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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)
Tidsramme: Up to 10 Weeks
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Up to 10 Weeks
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Safety and Tolerability of E6011
Tidsramme: Up to 10 Weeks
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. april 2014
Datoer for studieregistrering
Først innsendt
21. mai 2014
Først innsendt som oppfylte QC-kriteriene
22. mai 2014
Først lagt ut (Anslag)
23. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. oktober 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E6011-J081-002
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