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Studio di fase 2b che valuta la sicurezza e l'efficacia di AP01 nei partecipanti con PPF

3 novembre 2026 aggiornato da: Avalyn Pharma Inc.

Uno studio di fase 2b randomizzato, in doppio cieco, controllato con placebo che valuta la sicurezza e l'efficacia della soluzione inalatoria di pirfenidone (AP01) in partecipanti con fibrosi polmonare progressiva (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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

398

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Belgio
      • Leuven, Belgio, 3000
        • UZ Leuven
      • Liège, Belgio, 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
  • Francia
      • Angers, Francia, 49933
        • CHU Angers
      • Le Kremlin-Bicêtre, Francia, 94270
        • APHP - Hopital Bicetre
      • Paris, Francia, 75014
        • Hôpital Paris St Jozeph
      • Pessac, Francia, 33604
        • Hôpital Haut-Lévêque
    • Cedex NA
      • Rennes, Cedex NA, Francia, 35033
        • CHU de Rennes
    • Indre et Loire
      • Tours, Indre et Loire, Francia, 37000
        • CHU Tours
    • Lorraine
      • Metz, Lorraine, Francia, 57000
        • Robert Schuman Hospital UNEOS
    • Lyon
      • Lyon, Lyon, Francia, 69677
        • Louis Pradel Hospital
    • Montpellier
      • Montpellier, Montpellier, Francia, 34295
        • University of Montpellier
  • Germania
    • Bavaria
      • Munich, Bavaria, Germania, 81241
        • Pneumologisches Studienzentrum München-West
      • München, Bavaria, Germania, 81925
        • Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie
      • Rosenheim, Bavaria, Germania, 83022
        • RoMed Klinikum Rosenheim
    • Lower Saxony
      • Hanover, Lower Saxony, Germania, 30625
        • Medizinische Hochschule Hannover
    • Main Hessia
      • Frankfurt, Main Hessia, Germania, 60389
        • Studienzentrum Dr. Claus Keller
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germania, 45239
        • Ruhrlandklinik Essen, Klinik fuer Pneumologie
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germania, 55131
        • Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
    • Saxony
      • Leipzig, Saxony, Germania, 04103
        • Uniklinikum Leipzig Medizinische Klinik II - Bereich
    • State of Berlin
      • Berlin, State of Berlin, Germania, 12351
        • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
  • 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
  • Nuova Zelanda
    • Auckland
      • Auckland, Auckland, Nuova Zelanda, 1051
        • Greenlane Clinical Centre
    • Canterbury
      • Christchurch, Canterbury, Nuova Zelanda, 8011
        • Health New Zealand
    • Dunedine
      • Dunedin, Dunedine, Nuova Zelanda, 9016
        • Dunedin Hospital
    • South Tauranga
      • Tauranga, South Tauranga, Nuova Zelanda, 3112
        • Bay of Plenty Clinical School
  • Olanda
      • Rotterdam, Olanda, 3015 GD
        • Erasmus University Medical Center
    • Utrecht
      • Nieuwegein, Utrecht, Olanda, 3435
        • St Antoniusziekenhuis
  • Polonia
      • Lodz, Polonia, 90-153
        • Department of Pneumology of the University Hospital No 1
      • Lodz, Polonia, 90-602
        • PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
    • Bydgoszc
      • Bydgoszcz, Bydgoszc, Polonia, 85-079
        • Vitamed Galaj I Cichomski sp.j.
    • Krakow
      • Krakow, Krakow, Polonia, 30-688
        • University Hospital in Krakow
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polonia, 90-349
        • AppleTreeClinics Network
  • Regno Unito
      • Cambridge, Regno Unito, CB2 0BB
        • Royal Papworth Hospital
      • London, Regno Unito, SW3 6HP
        • Royal Brompton Hospital
      • Manchester, Regno Unito, M23 9LT
        • Manchester University NHS Foundation Trust
      • Nottingham, Regno Unito, NG5 1PB
        • Nottingham University NHS Trust
      • Stoke-on-Trent, Regno Unito, ST4 6QG
        • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
    • East Yorkshire
      • Cottingham, East Yorkshire, Regno Unito, HU16 5JQ
        • Hull University Teaching Hospital NHS Trust
    • Heartlands
      • Birmingham, Heartlands, Regno Unito, B95SS
        • Birmingham Heartlands Hospital
    • Leicester
      • Glenfield, Leicester, Regno Unito, LE3 9QP
        • Leicester Biomedical Research Centre - Respiratory Theme
    • London
      • London, London, Regno Unito, sw17 0QT
        • St George's University Hospitals NHS Foundation Trust
    • Midlands
      • Birmingham, Midlands, Regno Unito, B15 2GW
        • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
    • Northern Ireland
      • Londonderry, Northern Ireland, Regno Unito, BT46
        • C-TRIC Altnagelvin Hospital
    • Oxon
      • Oxford, Oxon, Regno Unito, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
    • South West
      • Exeter, South West, Regno Unito, EX2 5DW
        • Royal Devon
    • West Midlands
      • Wolverhampton, West Midlands, Regno Unito, WV10 0QP
        • The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
    • West Yorkshire
      • Leeds, West Yorkshire, Regno Unito, LS9 7TF
        • St James University Hospital - LTHT
  • Spagna
      • Barcelona, Spagna, 08908
        • Hospital Universitary de Bellvitge
      • Cadiz, Spagna, 11009
        • Hospital Universitario Puerta del Mar - Leon-Jimenez
    • Andalusia
      • Granada, Andalusia, Spagna, 18014
        • Hospital Universitario Virgen de las Nieves
    • Barcelona
      • Barcelona, Barcelona, Spagna, 08025
        • Hospital de Sant Pau y la Santa Creu
    • Cantabria
      • Santander, Cantabria, Spagna, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Madrid, Madrid, Spagna, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Madrid, Spagna, 28007
        • Hospital Gregorio Marañon
    • Málaga
      • Málaga, Málaga, Spagna, 29010
        • Hospital Universitario Virgen de la Victoria
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spagna, 33011
        • Hospital Universitario Central de Asturias
    • Sevilla
      • Seville, Sevilla, Spagna, 41013
        • Hospital Universitario Virgen del Rocío
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35205
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85259
        • Mayo Clinic- Scottsdale
    • California
      • Los Angeles, California, Stati Uniti, 90033
        • University of Southern California
      • Los Angeles, California, Stati Uniti, 90048
        • Cedars-Sinai
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA
      • Newport Beach, California, Stati Uniti, 92663
        • Newport Native MD, Inc.
      • Redding, California, Stati Uniti, 96001
        • Paradigm Clinical Research - Redding
      • San Francisco, California, Stati Uniti, 94143
        • University of California - San Francisco
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado, Anschutz Medical Campus
      • Denver, Colorado, Stati Uniti, 80206
        • National Jewish Health
    • Connecticut
      • Farmington, Connecticut, Stati Uniti, 06030
        • UCONN Health
      • New Haven, Connecticut, Stati Uniti, 06519
        • Yale University
    • Florida
      • Leesburg, Florida, Stati Uniti, 34748
        • Clinical Site Partners, LCC
      • Ocala, Florida, Stati Uniti, 34470
        • Renstar Medical Research
      • Winter Park, Florida, Stati Uniti, 32789
        • Clinical Site Partners
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
        • Piedmont Healthcare, Inc.
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
      • Evanston, Illinois, Stati Uniti, 60201
        • Endeavor Health
      • Maywood, Illinois, Stati Uniti, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • University of Maryland
      • Baltimore, Maryland, Stati Uniti, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Hannibal, Missouri, Stati Uniti, 63401
        • Hannibal Regional Healthcare System
    • New York
      • Mount Kisco, New York, Stati Uniti, 10549
        • Northern Westchester Hospital
      • Mount Kisco, New York, Stati Uniti, 10549
        • Northwell Health - Mount Kisco
      • New York, New York, Stati Uniti, 10032
        • Columbia University
      • New York, New York, Stati Uniti, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Stati Uniti, 10021
        • Weill Cornell
      • New York, New York, Stati Uniti, 10017
        • NYU Langone Health
      • The Bronx, New York, Stati Uniti, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University
      • Statesville, North Carolina, Stati Uniti, 28625
        • Piedmont HealthCare, PA
      • Wilmington, North Carolina, Stati Uniti, 28401
        • Accellacare
      • Winston-Salem, North Carolina, Stati Uniti, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic
    • Oregon
      • Beaverton, Oregon, Stati Uniti, 97008
        • The Oregon Clinic Pulmonary West
      • Bend, Oregon, Stati Uniti, 97701
        • Summit Health
      • Portland, Oregon, Stati Uniti, 97220
        • The Oregon Clinic Pulmonary East
      • Portland, Oregon, Stati Uniti, 97225
        • The Oregon Clinic Pulmonary West
    • Pennsylvania
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • The Pennsylvania State University
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Stati Uniti, 19140
        • Temple University
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, Stati Uniti, 29406
        • Lowcountry Lung and Critical Care
    • Tennessee
      • Franklin, Tennessee, Stati Uniti, 37067
        • Clinical Trials Center of Middle Tennessee
      • Nashville, Tennessee, Stati Uniti, 37204
        • Vanderbilt Lung Institute
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, Stati Uniti, 75246
        • Baylor Scott & White Research Institute, Baylor University Medical Center
      • El Paso, Texas, Stati Uniti, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine
      • Houston, Texas, Stati Uniti, 77030
        • The University of Texas Health Science Center
      • McKinney, Texas, Stati Uniti, 75069
        • Metroplex Pulmonary and Sleep Center, PA
    • Utah
      • Murray, Utah, Stati Uniti, 84157
        • Intermountain Medical Center
      • Salt Lake City, Utah, Stati Uniti, 84108
        • University of Utah Health
    • Virginia
      • Falls Church, Virginia, Stati Uniti, 22042
        • Inova Healthcare
    • Washington
      • Seattle, Washington, Stati Uniti, 98195
        • University of Washington
  • Turchia (Türkiye)
      • Adana, Turchia (Türkiye), 01240
        • Cukurova University Medical Faculty
      • Ankara, Turchia (Türkiye), 06010
        • Health Sciences University, Gulhane Faculty of Medicine
    • İzmir
      • Bornova, İzmir, Turchia (Türkiye), 35100
        • Ege University Medical Faculty Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AP01 High Dose BID

Pirfenidone Solution for Inhalation
Droga: AP01

Oral inhalation solution

Altri nomi:
  • Soluzione di pirfenidone
Sperimentale: AP01 Low Dose BID

Pirfenidone Solution for Inhalation
Droga: AP01

Oral inhalation solution

Altri nomi:
  • Soluzione di pirfenidone
Comparatore placebo: Placebo BID

Placebo solution for inhalation
Altro: Placebo

Placebo oral inhalation solution

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: Week 52

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 52 weeks

Change in lung fibrosis score.
52 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo
Lasso di tempo: 52 weeks

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Avalyn Pharma Inc.

Collaboratori

DevPro Biopharma

Investigatori

  • Direttore dello studio: Avalyn Pharma, Inc., Avalyn Pharma Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 aprile 2024

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

12 marzo 2024

Primo inviato che soddisfa i criteri di controllo qualità

19 marzo 2024

Primo Inserito (Effettivo)

25 marzo 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AP01-007

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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