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Fase 2b-studie som evaluerer sikkerheten og effektiviteten til AP01 hos deltakere med PPF

3. november 2026 oppdatert av: Avalyn Pharma Inc.

En randomisert, dobbeltblind, placebokontrollert, fase 2b-studie som evaluerer sikkerheten og effekten av Pirfenidon Solution for Inhalation (AP01) hos deltakere med progressiv lungefibrose (PPF)

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.

Studietype

Intervensjonell

Registrering (Faktiske)

398

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, 1427
        • Fundacion Respirar
      • Buenos Aires, Buenos Aires, Argentina, C1056AB
        • CINME
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABH
        • Hospital Italiano de Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto Ave Pulmo, Fundacion Enfisema
      • Monte Grande, Buenos Aires, Argentina, 1842
        • Clinica Monte Grande
      • Quilmes, Buenos Aires, Argentina, B1878
        • Centro Respiratorio Quilmes
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5003
        • Instituto de Medicina Respiratoria
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • CIMER Centro Integral de Medicina Respiratoria
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigaciones En Patologias Respiratorias
  • Australia
      • Canberra, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Kingswood, New South Wales, Australia, 2745
        • Nepean Lung & Sleep
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
      • Sydney, New South Wales, Australia, 2109
        • Macquarie University Clinical Trials Unit
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Perth West Australia
      • Nedlands, Perth West Australia, Australia, 6009
        • Institute for Respiratory Health
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Lung Research Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health
  • Belgia
      • Leuven, Belgia, 3000
        • UZ Leuven
      • Liège, Belgia, 4000
        • CHU de Liège
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver General Hospital
    • Ontario
      • Ajax, Ontario, Canada, L1S2J5
        • Dynamic Drug Advancement
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute McGill University Health Center
      • Québec, Quebec, Canada, G1V4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
      • Trois-Rivières, Quebec, Canada, G8T7A1
        • CIC Mauricie
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259
        • Mayo Clinic- Scottsdale
    • California
      • Los Angeles, California, Forente stater, 90033
        • University of Southern California
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai
      • Los Angeles, California, Forente stater, 90095
        • UCLA
      • Newport Beach, California, Forente stater, 92663
        • Newport Native MD, Inc.
      • Redding, California, Forente stater, 96001
        • Paradigm Clinical Research - Redding
      • San Francisco, California, Forente stater, 94143
        • University of California - San Francisco
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado, Anschutz Medical Campus
      • Denver, Colorado, Forente stater, 80206
        • National Jewish Health
    • Connecticut
      • Farmington, Connecticut, Forente stater, 06030
        • UCONN Health
      • New Haven, Connecticut, Forente stater, 06519
        • Yale University
    • Florida
      • Leesburg, Florida, Forente stater, 34748
        • Clinical Site Partners, LCC
      • Ocala, Florida, Forente stater, 34470
        • Renstar Medical Research
      • Winter Park, Florida, Forente stater, 32789
        • Clinical Site Partners
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Piedmont Healthcare, Inc.
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University
      • Evanston, Illinois, Forente stater, 60201
        • Endeavor Health
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Hannibal, Missouri, Forente stater, 63401
        • Hannibal Regional Healthcare System
    • New York
      • Mount Kisco, New York, Forente stater, 10549
        • Northern Westchester Hospital
      • Mount Kisco, New York, Forente stater, 10549
        • Northwell Health - Mount Kisco
      • New York, New York, Forente stater, 10032
        • Columbia University
      • New York, New York, Forente stater, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forente stater, 10021
        • Weill Cornell
      • New York, New York, Forente stater, 10017
        • NYU Langone Health
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University
      • Statesville, North Carolina, Forente stater, 28625
        • Piedmont HealthCare, PA
      • Wilmington, North Carolina, Forente stater, 28401
        • Accellacare
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic
    • Oregon
      • Beaverton, Oregon, Forente stater, 97008
        • The Oregon Clinic Pulmonary West
      • Bend, Oregon, Forente stater, 97701
        • Summit Health
      • Portland, Oregon, Forente stater, 97220
        • The Oregon Clinic Pulmonary East
      • Portland, Oregon, Forente stater, 97225
        • The Oregon Clinic Pulmonary West
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • The Pennsylvania State University
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Temple University
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, Forente stater, 29406
        • Lowcountry Lung and Critical Care
    • Tennessee
      • Franklin, Tennessee, Forente stater, 37067
        • Clinical Trials Center of Middle Tennessee
      • Nashville, Tennessee, Forente stater, 37204
        • Vanderbilt Lung Institute
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, Forente stater, 75246
        • Baylor Scott & White Research Institute, Baylor University Medical Center
      • El Paso, Texas, Forente stater, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forente stater, 77030
        • The University of Texas Health Science Center
      • McKinney, Texas, Forente stater, 75069
        • Metroplex Pulmonary and Sleep Center, PA
    • Utah
      • Murray, Utah, Forente stater, 84157
        • Intermountain Medical Center
      • Salt Lake City, Utah, Forente stater, 84108
        • University of Utah Health
    • Virginia
      • Falls Church, Virginia, Forente stater, 22042
        • Inova Healthcare
    • Washington
      • Seattle, Washington, Forente stater, 98195
        • University of Washington
  • Frankrike
      • Angers, Frankrike, 49933
        • CHU Angers
      • Le Kremlin-Bicêtre, Frankrike, 94270
        • APHP - Hopital Bicetre
      • Paris, Frankrike, 75014
        • Hôpital Paris St Jozeph
      • Pessac, Frankrike, 33604
        • Hôpital Haut-Lévêque
    • Cedex NA
      • Rennes, Cedex NA, Frankrike, 35033
        • CHU de Rennes
    • Indre et Loire
      • Tours, Indre et Loire, Frankrike, 37000
        • CHU Tours
    • Lorraine
      • Metz, Lorraine, Frankrike, 57000
        • Robert Schuman Hospital UNEOS
    • Lyon
      • Lyon, Lyon, Frankrike, 69677
        • Louis Pradel Hospital
    • Montpellier
      • Montpellier, Montpellier, Frankrike, 34295
        • University of Montpellier
  • Italia
    • Ancona
      • Torrette, Ancona, Italia, 60126
        • A.O.U. delle Marche - Ospedale di Torrette
    • Campania
      • Naples, Campania, Italia, 80131
        • Università degli Studi di Napoli Federico II - Ospedale Monaldi
      • Naples, Campania, Italia, 80131
        • Azienda Ospedaliera dei Colli - Ospedale Monaldi
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italia, 40138
        • IRCCS AOU di Bologna - Policlinico Sant' Orsola
    • Giulia
      • Venezia, Giulia, Italia, 34149
        • Azienda Sanitaria Universitaria Giuliano Isontina
    • Lombardy
      • Pavia, Lombardy, Italia, 27100
        • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
    • Milano
      • Milan, Milano, Italia, 20123
        • Ospedale San Giuseppe
      • Rozzano, Milano, Italia, 20089
        • HUMANITAS Research Hospital
    • Sicily
      • Catania, Sicily, Italia, 95123
        • A.O.U. Policlinico G. Rodolico
  • Nederland
      • Rotterdam, Nederland, 3015 GD
        • Erasmus University Medical Center
    • Utrecht
      • Nieuwegein, Utrecht, Nederland, 3435
        • St Antoniusziekenhuis
  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Health New Zealand
    • Dunedine
      • Dunedin, Dunedine, New Zealand, 9016
        • Dunedin Hospital
    • South Tauranga
      • Tauranga, South Tauranga, New Zealand, 3112
        • Bay of Plenty Clinical School
  • Polen
      • Lodz, Polen, 90-153
        • Department of Pneumology of the University Hospital No 1
      • Lodz, Polen, 90-602
        • PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
    • Bydgoszc
      • Bydgoszcz, Bydgoszc, Polen, 85-079
        • Vitamed Galaj I Cichomski sp.j.
    • Krakow
      • Krakow, Krakow, Polen, 30-688
        • University Hospital in Krakow
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 90-349
        • AppleTreeClinics Network
  • Spania
      • Barcelona, Spania, 08908
        • Hospital Universitary de Bellvitge
      • Cadiz, Spania, 11009
        • Hospital Universitario Puerta del Mar - Leon-Jimenez
    • Andalusia
      • Granada, Andalusia, Spania, 18014
        • Hospital Universitario Virgen de las Nieves
    • Barcelona
      • Barcelona, Barcelona, Spania, 08025
        • Hospital de Sant Pau y la Santa Creu
    • Cantabria
      • Santander, Cantabria, Spania, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Madrid, Madrid, Spania, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Madrid, Spania, 28007
        • Hospital Gregorio Marañon
    • Málaga
      • Málaga, Málaga, Spania, 29010
        • Hospital Universitario Virgen de la Victoria
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spania, 33011
        • Hospital Universitario Central de Asturias
    • Sevilla
      • Seville, Sevilla, Spania, 41013
        • Hospital Universitario Virgen del Rocío
  • Storbritannia
      • Cambridge, Storbritannia, CB2 0BB
        • Royal Papworth Hospital
      • London, Storbritannia, SW3 6HP
        • Royal Brompton Hospital
      • Manchester, Storbritannia, M23 9LT
        • Manchester University NHS Foundation Trust
      • Nottingham, Storbritannia, NG5 1PB
        • Nottingham University NHS Trust
      • Stoke-on-Trent, Storbritannia, ST4 6QG
        • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
    • East Yorkshire
      • Cottingham, East Yorkshire, Storbritannia, HU16 5JQ
        • Hull University Teaching Hospital NHS Trust
    • Heartlands
      • Birmingham, Heartlands, Storbritannia, B95SS
        • Birmingham Heartlands Hospital
    • Leicester
      • Glenfield, Leicester, Storbritannia, LE3 9QP
        • Leicester Biomedical Research Centre - Respiratory Theme
    • London
      • London, London, Storbritannia, sw17 0QT
        • St George's University Hospitals NHS Foundation Trust
    • Midlands
      • Birmingham, Midlands, Storbritannia, B15 2GW
        • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
    • Northern Ireland
      • Londonderry, Northern Ireland, Storbritannia, BT46
        • C-TRIC Altnagelvin Hospital
    • Oxon
      • Oxford, Oxon, Storbritannia, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
    • South West
      • Exeter, South West, Storbritannia, EX2 5DW
        • Royal Devon
    • West Midlands
      • Wolverhampton, West Midlands, Storbritannia, WV10 0QP
        • The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
    • West Yorkshire
      • Leeds, West Yorkshire, Storbritannia, LS9 7TF
        • St James University Hospital - LTHT
  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye), 01240
        • Cukurova University Medical Faculty
      • Ankara, Tyrkia (Türkiye), 06010
        • Health Sciences University, Gulhane Faculty of Medicine
    • İzmir
      • Bornova, İzmir, Tyrkia (Türkiye), 35100
        • Ege University Medical Faculty Hospital
  • Tyskland
    • Bavaria
      • Munich, Bavaria, Tyskland, 81241
        • Pneumologisches Studienzentrum München-West
      • München, Bavaria, Tyskland, 81925
        • Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie
      • Rosenheim, Bavaria, Tyskland, 83022
        • RoMed Klinikum Rosenheim
    • Lower Saxony
      • Hanover, Lower Saxony, Tyskland, 30625
        • Medizinische Hochschule Hannover
    • Main Hessia
      • Frankfurt, Main Hessia, Tyskland, 60389
        • Studienzentrum Dr. Claus Keller
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Tyskland, 45239
        • Ruhrlandklinik Essen, Klinik fuer Pneumologie
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Tyskland, 55131
        • Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
    • Saxony
      • Leipzig, Saxony, Tyskland, 04103
        • Uniklinikum Leipzig Medizinische Klinik II - Bereich
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 12351
        • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participant meets criteria for PPF, as follows:
  • In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as:

Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator):

  1. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments

  2. Relative decline in FVC ≥5% to <10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria:

    • Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR

    • Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example:

      • Increased extent or severity of traction bronchiectasis and bronchiolectasis
      • New ground-glass opacity with traction bronchiectasis
      • New fine reticulation
      • Increased extent or increased coarseness of reticular abnormality
      • New or increased honeycombing
      • Increased lobar volume loss

  3. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist

    • Meeting all of the following criteria during the Screening Period:

a. FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits).

• For subjects already on background therapy (nintedanib or nerandomilast 18 mg twice daily [up to 30% of subjects]): Must have been on background therapy for at least 12 weeks prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued background therapy prior to Screening: Must have been off for a minimum of 12 weeks.

Exclusion Criteria:

  • Current treatment with oral pirfenidone or nerandomilast 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening.

  • Elevated liver enzymes and liver injury at Screening defined as:

    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
    2. Bilirubin >2.0 x ULN

  • Renal disease with a creatinine clearance < 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once.

  • Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.

  • Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.

  • Significant clinical worsening of PPF between Screening Visit 1 and Visit 3

  • Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AP01 High Dose BID

Pirfenidone Solution for Inhalation
Legemiddel: AP01

Oral inhalation solution

Andre navn:
  • Pirfenidon løsning
Eksperimentell: AP01 Low Dose BID

Pirfenidone Solution for Inhalation
Legemiddel: AP01

Oral inhalation solution

Andre navn:
  • Pirfenidon løsning
Placebo komparator: Placebo BID

Placebo solution for inhalation
Annen: Placebo

Placebo oral inhalation solution

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
Tidsramme: Week 52

Change from baseline in forced vital capacity (FVC) (mL)
Week 52

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)
Tidsramme: 52 weeks

Time to disease progression
52 weeks
To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)
Tidsramme: 52 weeks

Absolute change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score. The L-PF is a 44-item questionnaire to assess how impacted a participant is by disease symptoms on a scale from 0 (Not at all) to 4 (Extremely). The higher the summary score, the greater the impairment.
52 weeks
To evaluate the change from baseline in quantitative lung fibrosis score.
Tidsramme: 52 weeks

Change in lung fibrosis score.
52 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo
Tidsramme: 52 weeks

Incidents of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent deaths
52 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Avalyn Pharma Inc.

Samarbeidspartnere

DevPro Biopharma

Etterforskere

  • Studieleder: Avalyn Pharma, Inc., Avalyn Pharma Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. april 2024

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

12. mars 2024

Først innsendt som oppfylte QC-kriteriene

19. mars 2024

Først lagt ut (Faktiske)

25. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AP01-007

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere