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Sicherheit, Pharmakokinetik und Wirksamkeit von PP405 bei Erwachsenen mit AGA

29. September 2026 aktualisiert von: Pelage Pharmaceuticals, Inc.

Eine randomisierte, multizentrische, doppelblinde, fahrzeugkontrollierte Phase-2a-Studie zur Bewertung der Sicherheit, Pharmakokinetik und Wirksamkeit von PP405 bei Erwachsenen mit androgenetischer Alopezie

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Tatsächlich)

78

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: PP405 0.05% Topical Gel

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

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

Andere Namen:
  • PP405 0.05%
Placebo-Komparator: 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.
Arzneimittel: PP405 0.05% Topical Gel

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

Andere Namen:
  • PP405 0.05%
Arzneimittel: Topical Vehicle Gel

Vehicle = placebo topical gel

Andere Namen:
  • Topisches Placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Subjects With Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pharmacokinetics of PP405
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pelage Pharmaceuticals, Inc.

Ermittler

  • Studienstuhl: Christina Weng, Pelage Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Juni 2024

Primärer Abschluss (Tatsächlich)

16. Juli 2025

Studienabschluss (Tatsächlich)

1. Oktober 2025

Studienanmeldedaten

Zuerst eingereicht

26. April 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. April 2024

Zuerst gepostet (Tatsächlich)

1. Mai 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PP405-2001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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