- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04464681
Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects
29. august 2021 opdateret af: Tomoko Hasunuma, Kitasato University
A Randomized, Double-Blind, Placebo-Controlled, Multiple Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tokyo, Japan, 108-8642
- Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 49 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study
- (1)Japanese Healthy Male subjects
- (2)Age 20 to less than 50 years of age
- (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination
- (4)Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- (1)Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
- (2)Past medical history of cancer, cerebral infarction or cardiac infarction
- (3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation.
- (4)Presence or past history of epilepsy.
- (5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
- (6)heart rate(HR) >= 100 bpm at the screening examination
- (7)The corrected QT interval(QTcF) >= 440 ms at the screening examination
- (8)brain natriuretic peptide(BNP) > 40 pg/mL at the screening examination
- (9)K<3.6 mEq/L at the screening examination
- (10)Past history or suspect of aldosteronism.
- (11)Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
- (12)Cre>1.10 mg/dL, <0.85 mg/dL at the screening examination
- (13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL of 200 mL / blood component donation within 4weeks prior to the first administration.
- (14)Use of prescription drug, over-the-counter medications (except eye drops for dryness, sanitizer for preventing infection), or herbal medication within 4 weeks prior to study medication.
- (15)Subject who consumed furanocoumarin containing food within 7 days prior to study medication.
- (16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to study medication.
- (17)Subject who was administered of another investigational drug within16 weeks prior to agree to participate in this study.
- (18)Subject who was administered M201-A in the past.
- (19)Subject who smoke within 90 day prior to study medication or who cannot quit smoking during the study period.
- (20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV) antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test. Subject with positive result in Coronavirus(COVID-19) test at the screening or at the hospitalization.
- (21) Presence or past history of drug/alcohol abuse.
- (22)Subject who do not use medically acceptable contraceptive method until 90 days after the final study drug administration.
- (23)Subject who investigator judges ineligible for other reasons
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
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Aktivt stof: M201-A Administrationsvej: kontinuerlig intravenøs injektion
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Placebo komparator: Placebo
Placebo: M201-A Placebo Route of administration: continuous intravenous injection
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Placebo: M201-A Placebo Route of administration: continuous intravenous injection
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of participants with adverse events as a measure of safety and tolerability
Tidsramme: Throughout the study duration up to day 11
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Number of participants with adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
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Throughout the study duration up to day 11
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. marts 2020
Primær færdiggørelse (Faktiske)
28. november 2020
Studieafslutning (Faktiske)
30. november 2020
Datoer for studieregistrering
Først indsendt
5. juli 2020
Først indsendt, der opfyldte QC-kriterier
8. juli 2020
Først opslået (Faktiske)
9. juli 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- M201-A-CT-003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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University of AlbertaTrukket tilbageHæmoragisk slagtilfælde | Reversibelt cerebralt vasokonstriktionssyndrom | Cerebral venøs sinus trombose | Hovedpine, migræne | Slagtilfælde (CVA) eller TIA | Botulinumtoksiner, type A | Carotisdissektionsarterie | Vertebral dissektionsarterieCanada