Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Sikkerhed, farmakokinetik og effektivitet af PP405 hos voksne med AGA

29. september 2026 opdateret af: Pelage Pharmaceuticals, Inc.

Et randomiseret, multicenter, dobbeltblindt, køretøjsstyret, fase 2a-studie for at vurdere sikkerheden, farmakokinetikken og effektiviteten af ​​PP405 hos voksne med androgenetisk alopeci

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

78

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

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

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

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: PP405 0.05% Topical Gel

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

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

Andre navne:
  • 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.
Medicin: PP405 0.05% Topical Gel

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

Andre navne:
  • PP405 0.05%
Medicin: Topical Vehicle Gel

Vehicle = placebo topical gel

Andre navne:
  • Aktuel placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Subjects With Adverse Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics of PP405
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Pelage Pharmaceuticals, Inc.

Efterforskere

  • Studiestol: Christina Weng, Pelage Pharmaceuticals

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)

5. juni 2024

Primær færdiggørelse (Faktiske)

16. juli 2025

Studieafslutning (Faktiske)

1. oktober 2025

Datoer for studieregistrering

Først indsendt

26. april 2024

Først indsendt, der opfyldte QC-kriterier

26. april 2024

Først opslået (Faktiske)

1. maj 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PP405-2001

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

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 .

Abonner