Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Veiligheid, farmacokinetiek en werkzaamheid van PP405 bij volwassenen met AGA

29 september 2026 bijgewerkt door: Pelage Pharmaceuticals, Inc.

Een gerandomiseerde, multicentrische, dubbelblinde, voertuiggecontroleerde fase 2a-studie om de veiligheid, farmacokinetiek en werkzaamheid van PP405 bij volwassenen met androgenetische alopecia te beoordelen

The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

78

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Encinitas, California, Verenigde Staten, 92024
        • California Dermatology & Clinical Research Institute
      • Thousand Oaks, California, Verenigde Staten, 91320
        • Clinical Trials Research Institute
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Minnesota
      • New Brighton, Minnesota, Verenigde Staten, 55112
        • Minnesota Clinical Study Center
    • Texas
      • Austin, Texas, Verenigde Staten, 78759
        • DermResearch
      • Sugar Land, Texas, Verenigde Staten, 77479
        • Stride Clinical Research LLC
    • Utah
      • South Jordan, Utah, Verenigde Staten, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23502
        • Virginia Clinical Research, Inc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Male or female subjects aged 18 to 55 years.
  2. Able and willing to provide written informed consent.
  3. Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
  4. Agree to comply with protocol procedures

Exclusion Criteria:

  1. Concomitant diagnosis of non-AGA forms of alopecia.
  2. Use of other hair loss treatments within periods specified in protocol.
  3. Use of excluded medications as specified in protocol.
  4. Diagnosis of other medical conditions as specified in protocol.
  5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: PP405 0.05% Topical Gel

PP405 0.05% Topical Gel applied once daily for 28 days.
Geneesmiddel: PP405 0.05% Topical Gel

Medicated topical gel containing PP405 0.05%, applied once daily to the scalp

Andere namen:
  • PP405 0.05%
Placebo-vergelijker: Topical Vehicle Gel, then PP405 0.05% Topical Gel

Topical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension.
Geneesmiddel: PP405 0.05% Topical Gel

Medicated topical gel containing PP405 0.05%, applied once daily to the scalp

Andere namen:
  • PP405 0.05%
Geneesmiddel: Topical Vehicle Gel

Vehicle = placebo topical gel

Andere namen:
  • Topische Placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Subjects With Adverse Events
Tijdsspanne: Baseline to Day 84 of the randomized portion of the study

An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Baseline to Day 84 of the randomized portion of the study
Percentage of Subjects With Adverse Events
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study

An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Baseline to Day 84 of the open label extension portion of the study
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Tijdsspanne: Post-dose at day 28 of the randomized portion of the study

Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Post-dose at day 28 of the randomized portion of the study
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Tijdsspanne: Post-dose at day 84 of the open label extension portion of the study

Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Post-dose at day 84 of the open label extension portion of the study
Change From Baseline in Blood Pressure
Tijdsspanne: Baseline to Day 84 of the randomized portion of the study

Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline)
Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Pulse Rate
Tijdsspanne: Baseline to Day 84 of the randomized portion of the study

Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline)
Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Temperature
Tijdsspanne: Baseline to Day 84 of the randomized portion of the study

Change from baseline in temperature in the safety analysis population (day 84 minus baseline)
Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Respiratory Rate
Tijdsspanne: Baseline to Day 84 of the randomized portion of the study

Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline)
Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Weight
Tijdsspanne: Baseline to Day 84 of the randomized portion of the study

Change from baseline in weight in the safety analysis population (day 84 minus baseline)
Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Blood Pressure
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study

Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline)
Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Pulse Rate
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study

Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Temperature
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study

Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline)
Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Respiratory Rate
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study

Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Weight
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study

Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline)
Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Mean Electrocardiogram Heart Rate
Tijdsspanne: Baseline to day 28 of the randomized portion of the study

Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)
Baseline to day 28 of the randomized portion of the study
Change From Baseline in Electrocardiogram (ECG) Results
Tijdsspanne: Baseline to day 28 of the randomized portion of the study

Electrocardiograms results were compared to baseline (day 28 minus baseline)
Baseline to day 28 of the randomized portion of the study
Change From Baseline in Mean Electrocardiogram Heart Rate
Tijdsspanne: Baseline to day 84 of the open label extension portion of the study

Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline)
Baseline to day 84 of the open label extension portion of the study
Change From Baseline in Electrocardiograms (ECGs)
Tijdsspanne: Baseline to day 84 of the open label extension portion of the study

Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline)
Baseline to day 84 of the open label extension portion of the study
Abnormal Laboratory Values
Tijdsspanne: Day 28 post baseline in the randomized portion of the study

Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Day 28 post baseline in the randomized portion of the study
Abnormal Laboratory Values
Tijdsspanne: Day 84 post baseline in the open label extension portion of the study

Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Day 84 post baseline in the open label extension portion of the study

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pharmacokinetics of PP405
Tijdsspanne: Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28

To assess the concentration of PP405 in plasma
Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28
Pharmacokinetics of PP405
Tijdsspanne: Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84

To assess the concentration of PP405 in plasma
Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pelage Pharmaceuticals, Inc.

Onderzoekers

  • Studie stoel: Christina Weng, Pelage Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 juni 2024

Primaire voltooiing (Werkelijk)

16 juli 2025

Studie voltooiing (Werkelijk)

1 oktober 2025

Studieregistratiedata

Eerst ingediend

26 april 2024

Eerst ingediend dat voldeed aan de QC-criteria

26 april 2024

Eerst geplaatst (Werkelijk)

1 mei 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PP405-2001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren