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Sikkerhed, tolerabilitet, farmakokinetik og beskyttende effekt af MAM01 hos raske voksne

18. maj 2026 opdateret af: Gates Medical Research Institute

Et fase 1, dosiseskalering, dobbeltblindet, placebokontrolleret klinisk forsøg med kontrollerede humane malariainfektioner (CHMI) for at evaluere sikkerhed, tolerabilitet, farmakokinetik og beskyttende effektivitet af et anti-malaria humant monoklonalt antistof, MAM01, i sund, malaria-naiv Voksne

Dette er et First-in-Human (FiH) dobbeltblindt, randomiseret, placebokontrolleret, todelt dosis-eskaleringsforsøg med MAM01 monoklonalt antistof (mAb) rettet mod Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). Denne undersøgelse vil evaluere sikkerheden, tolerabiliteten, farmakokinetikken (PK) og den beskyttende effekt af MAM01, såvel som sikkerheden og PK ved gentagen subkutan (SC) dosering.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

63

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Center for Vaccine Development and Global Health, 685 W. Baltimore Street

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Deltagere, der er raske som bestemt ved medicinsk vurdering, herunder sygehistorie, fysisk undersøgelse og laboratorietests.
  • Body Mass Index (BMI) 18 til 30 kg pr. kvadratmeter (kg/m^2) (inklusive) til et maksimum på 220 pund.

  • Både mænd og kvinder er berettiget til at deltage i henhold til følgende:

    en. Kvindelige deltagere, der fysisk er i stand til at blive gravide, har mindst én negativ graviditetstest under screening, på tilmeldingsdagen, før administration af undersøgelsesprodukt (IP), før CHM og ved starten af ​​antimalariabehandling, og som accepterer at bruge effektiv prævention at undgå graviditet fra 28 dage før tilmelding gennem afslutning af forsøgsbesøgene.

  • I stand til at give underskrevet informeret samtykke, som omfatter overholdelse af kravene og begrænsninger, der er anført i formularen til informeret samtykke (ICF) og i denne protokol, og fuldførelse af en forståelsestest, hvis han/hun kan deltage i CHMI-proceduren.
  • Rapporteret færdiggørelse af primær Coronavirus Disease (COVID) vaccineserie er dokumenteret.

Eksklusionskriterier:

  • Akut sygdom eller feber ≥99,5°Fahrenheit (F) (eller >37,5 grader Celsius) på doseringsdagen.
  • Kvinder, der er gravide eller ammer.
  • Evidens og/eller anamnese med klinisk signifikant(e) medicinsk(e) tilstand(er) som vurderet af investigator, herunder maligniteter, diabetes mellitus og ustabil eller ukontrolleret hypertension.
  • En 5-årig kardiovaskulær risiko på >10 % ved brug af Gaziano nomogram.
  • Anamnese med enhver autoimmun sygdom eller immundefekt eller anden svækkelse af immunsystemet, inklusive men ikke begrænset til humant immundefektvirus (HIV), autoimmune tilstande eller immunsuppressiv terapi.
  • Deltagelse i et interventionelt klinisk forsøg og/eller modtagelse af ethvert forsøgslægemiddel inden for 180 dage før administration af forsøgslægemidlet på dag 1.
  • Forventet brug af medicin, der vides at forårsage lægemiddelreaktioner med chloroquin eller atovaquoneproguanil (Malarone), såsom cimetidin, metoclopramid, antacida og kaolin.

Bemærk: Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Del A: Enkelt stigende dosis (SAD): Dosiseskalering, kohorte 1: MAM01 og placebo Intravenøs (IV)
2 sentinel-deltagere vil blive randomiseret i forholdet 1:1 til at modtage MAM01 1,5 milligram pr. kilogram (mg/kg) IV eller placebo. Efter mindst en 24-timers sikkerhedsgennemgangsperiode vil de 6 resterende deltagere i kohorte 1 blive randomiseret i forholdet 5:1 til at modtage MAM01 1,5 mg/kg IV eller placebo.
Biologisk: MAM01 1,5 mg/kg
1,5 mg/kg MAM01 vil blive indgivet via IV-vej.
Biologisk: Placebo
Placebo vil blive givet via IV-vejen.
Biologisk: Placebo
Placebo vil blive administreret ad SC-vejen.
Eksperimentel: Del A: SAD-dosering: Dosiseskalering Kohorte 2: MAM01 og placebo SC
7 deltagere vil blive tilfældigt tildelt i forholdet 6:1 til at modtage MAM01 5 mg/kg SC eller placebo
Biologisk: Placebo
Placebo vil blive givet via IV-vejen.
Biologisk: Placebo
Placebo vil blive administreret ad SC-vejen.
Biologisk: MAM01 5 mg/kg
5 mg/kg MAM01 vil blive administreret via SC-vej.
Biologisk: MAM01 5 mg/kg
5 mg/kg MAM01 vil blive administreret via IV-vej.
Eksperimentel: Del A: SAD-dosering: Dosiseskalering Kohorte 3: MAM01 og placebo IV
7 deltagere vil blive tilfældigt tildelt i forholdet 6:1 til at modtage MAM01 5 mg/kg IV eller placebo.
Biologisk: Placebo
Placebo vil blive givet via IV-vejen.
Biologisk: Placebo
Placebo vil blive administreret ad SC-vejen.
Biologisk: MAM01 5 mg/kg
5 mg/kg MAM01 vil blive administreret via SC-vej.
Biologisk: MAM01 5 mg/kg
5 mg/kg MAM01 vil blive administreret via IV-vej.
Eksperimentel: Del A: SAD-dosering: Dosiseskalering Kohorte 4: MAM01 og placebo IV
8 deltagere vil blive tilfældigt tildelt i forholdet 6:2 til at modtage MAM01 10 mg/kg IV eller placebo.
Biologisk: Placebo
Placebo vil blive givet via IV-vejen.
Biologisk: Placebo
Placebo vil blive administreret ad SC-vejen.
Biologisk: MAM01 10 mg/kg
10 mg/kg MAM01 vil blive administreret via IV-vej.
Eksperimentel: Del A: SAD-dosering: Dosiseskalering Kohorte 5: MAM01 og placebo IV
7 deltagere vil blive tilfældigt tildelt i forholdet 6:1 til at modtage MAM01 40 mg/kg IV eller placebo
Biologisk: Placebo
Placebo vil blive givet via IV-vejen.
Biologisk: Placebo
Placebo vil blive administreret ad SC-vejen.
Biologisk: MAM01 40 mg/kg
40 mg/kg MAM01 vil blive administreret via IV-vej.
Eksperimentel: Del A: Multiple Ascending Dose (MAD) (Gentag dosering): MAM01
Deltagere fra kohorte 2 og fra kohorte 3 vil modtage 5 mg/kg MAM01 SC.
Biologisk: MAM01 5 mg/kg
5 mg/kg MAM01 vil blive administreret via SC-vej.
Biologisk: MAM01 5 mg/kg
5 mg/kg MAM01 vil blive administreret via IV-vej.
Eksperimentel: Del B: Dosisudvidelseskohorte 6: Gruppe 1: MAM01
6 deltagere vil modtage en 450 mg SC dosis af MAM01. Dosis blev valgt ved at anvende en PK-farmakodynamisk (PD) model fra del A-dataene til at estimere en (datadrevet) beskyttelsestærskel ved kontrolleret human malariainfektion (CHMI).
Biologisk: MAM01 450 mg
MAM01 vil blive administreret via SC rute.
Eksperimentel: Del B: Dosisudvidelseskohorte 6: Gruppe 2: MAM01
8 deltagere vil modtage en 600 mg SC dosis af MAM01. Dosis blev valgt ved at anvende en PK-PD-model fra del A-dataene til at estimere en (datadrevet) beskyttelsestærskel ved CHMI
Biologisk: MAM01 600 mg
MAM01 vil blive administreret via SC rute.
Eksperimentel: Del B: Dosisudvidelseskohorte 6: Gruppe 3: MAM01
8 deltagere vil modtage 900 mg SC dosis af MAM01. Dosis blev valgt ved at anvende en PK-PD-model fra del A-dataene til at estimere en (datadrevet) beskyttelsestærskel ved CHMI.
Biologisk: MAM01 900 mg
MAM01 vil blive administreret via SC rute.
Eksperimentel: Intern smittekontrol
6 deltagere vil blive tilmeldt en ikke-randomiseret gruppe forud for CHMI. Disse deltagere modtager ingen behandling og fungerer som smittekontrol
Andet: Kontrollere
Ingen medicin eller placebo vil blive administreret.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Reporting Solicited Adverse Events (AEs) in the Subcutaneous Cohorts
Tidsramme: Day 1 to Day 7 post dose
Solicited AEs were defined events participants were specifically asked about, which were recorded by participants in the memory aid card. Solicited AES included local injection site AEs (pain, redness, swelling, itching and bruising) and systemic AEs (fever, chills, headache, fatigue, nausea, muscle pain and joint pain). A Solicited AE does not necessarily have a causal relationship with the intervention.
Day 1 to Day 7 post dose
Number of Participants Reporting Unsolicited Adverse Events
Tidsramme: Through Day 28 post dose
In this study an unsolicited AE is any AE not captured as a solicited AE in the Memory Aid Card between Day 0 and Day 7 after MAM01 dosing, and all AEs occurring after Day 7 post dose were collected as Unsolicited AEs.
Through Day 28 post dose
Number of Participants Reporting Serious Adverse Events (SAEs) Including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events Special Interest (AESIs)
Tidsramme: Up to Day 168
A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting.
Up to Day 168
Number of Participants Who Received 2 Doses Reporting SUSARs, SAEs and AESIs
Tidsramme: Through Day 336
A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting.
Through Day 336
Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters
Tidsramme: Through Day 336
Blood samples were collected for the assessment of alanine transaminase, aspartate aminotransferase, alkaline phosphatase, total carbon-dioxide (CO2), chloride, total bilirubin, creatinine, blood urea nitrogen, glucose, albumin, total protein, sodium and potassium.
Through Day 336
Number of Participants With Clinically Significant Changes in Hematology Parameters
Tidsramme: Through Day 336
Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, platelet count, and white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, and monocytes.
Through Day 336

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximal Observed Concentration (Cmax) Following Single Dose of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Cmax Following Repeat Dosing of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours, Day 1: 24 hours, Day 2: 48 hours, Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours, Day 1: 24 hours, Day 2: 48 hours, Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Area Under the Curve (AUC) From Time=0 to the Last Measurable Concentration (AUC0-t) Following Single Dose of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
AUC (0-t) Following Repeat Dosing of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Partial AUC's Time= 0 to the CHMI Challenge (AUC0-CHMI) of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Concentration at the Time of CHMI (CCHMI) of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Blood Terminal Elimination Rate Constant (λz) of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Terminal Half Life (t1/2) Following Single Dose of MAM01
Tidsramme: Time Frame: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Time Frame: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
t1/2 Following Repeat Dosing of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
AUC From Time=0 Extrapolated to Infinity (AUC0-infinity) of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Absolute Bioavailability of SC Formulation Following Repeated Dosing of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224, 280 and 378 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224, 280 and 378 post-dose
Accumulation Ratio (AUC0-168) Following Repeated Doses of MAM01
Tidsramme: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140 and 168 post-dose
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. The accumulation ratio was calculated as the ratio of AUC (0-168) (post first dose) to AUC (210-378) (post redose).
Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140 and 168 post-dose
Number of Participants With Confirmed Pf Infection Assessed by Quantitative Polymerase Chain Reaction Assay (qRT-PCR) After CHMI
Tidsramme: Up to Day 27 post-CHMI
The characterization of protective efficacy against Pf following CHMI challenge, was assessed by evaluating the presence or absence of Pf infection as determined by qRT-PCR after CHMI (planned through 4 weeks post-CHMI) and evaluating the time to parasitemia after CHMI in each cohort.
Up to Day 27 post-CHMI
Time to Parasitemia After CHMI
Tidsramme: Up to Day 27 post-CHMI
Parasitemia was assessed by qRT-PCR up to Day 27 following CHMI. In addition, a thick blood smear was prepared for microscopic analysis, which was examined only once the first qRT-PCR sample tested positive. Daily parasitemia monitoring continued until the participant had a confirmed initial positive qRT-PCR. The first positive qRT-PCR triggered either a second PCR test or microscopic analysis of the blood smear. Once two positive results were obtained, rescue therapy was initiated.
Up to Day 27 post-CHMI
Cohorts 1, 4 and 5: Numbers of Participants With Seroconversion
Tidsramme: Up to Day 280
The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints.
Up to Day 280
Cohorts 2 and 3: Numbers of Participants Receiving 2 Doses With Seroconversion
Tidsramme: Up to Day 378
The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints.
Up to Day 378
Cohort 6: Numbers of Participants With Seroconversion
Tidsramme: Up to Day 84
The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints.
Up to Day 84

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gates Medical Research Institute

Efterforskere

  • Studieleder: +1 866 789 5767, Gates Medical Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

14. august 2023

Primær færdiggørelse (Faktiske)

13. december 2024

Studieafslutning (Faktiske)

13. december 2024

Datoer for studieregistrering

Først indsendt

26. maj 2023

Først indsendt, der opfyldte QC-kriterier

26. maj 2023

Først opslået (Faktiske)

6. juni 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Gates MRI-MAM01-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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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