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A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure

8. juli 2026 oppdatert av: Tarsus Pharmaceuticals, Inc.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TP-05 in Healthy Participants at High Risk of Tick Exposure

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, double-blind, placebo-controlled study conducted in healthy adult participants prior to anticipated exposure to Lyme Borreliosis. Participants will be randomized to receive either TP05 or placebo according to a predefined dosing schedule. Safety will be evaluated through adverse event monitoring, clinical laboratory assessments, vital signs, and physical examinations. The study will consist of a screening period, a treatment period (up to 24 weeks) and a safety follow up period. Participants will be randomized to receive one of two treatment regimens of TP-05 or placebo. Participants will be followed up for approximately 15 months and evaluated further for tick bites or symptoms of Lyme borreliosis.

Studietype

Intervensjonell

Registrering (Faktiske)

722

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Maryland
      • Pikesville, Maryland, Forente stater, 21208
        • Study Site
    • Massachusetts
      • Brookline, Massachusetts, Forente stater, 02445
        • Study Site
      • Fall River, Massachusetts, Forente stater, 02723
        • Study Site
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Study Site
    • New Jersey
      • Marlboro, New Jersey, Forente stater, 07746
        • Study Site
    • New York
      • Albany, New York, Forente stater, 12205
        • Study Site
      • Binghamton, New York, Forente stater, 13905
        • Study Site
      • Buffalo, New York, Forente stater, 14217
        • Study Site
      • East Syracuse, New York, Forente stater, 13057
        • Study Site
      • Middletown, New York, Forente stater, 10941
        • Study Site
      • New York, New York, Forente stater, 10036
        • Study Site
      • Rochester, New York, Forente stater, 14609
        • Study Site
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 16508
        • Study Site
      • Hatboro, Pennsylvania, Forente stater, 19040
        • Study Site
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Study Site
      • Pittsburgh, Pennsylvania, Forente stater, 15236
        • Study Site
      • Pottstown, Pennsylvania, Forente stater, 19464
        • Study Site
      • West Chester, Pennsylvania, Forente stater, 19380
        • Study Site
    • Rhode Island
      • Warwick, Rhode Island, Forente stater, 02886
        • Study Site

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Overtly healthy adult participants aged 18 to 70 years
  • Able to provide written informed consent
  • Willing and able to comply with study procedures
  • At high risk of exposure to ticks
  • Contraceptive use by men and women consistent with local regulations

Exclusion Criteria:

  • Prior exposure to TP05 or any isooxazoline in the last 12 months
  • Known hypersensitivity to TP05 or related compounds
  • Clinically significant medical conditions that may interfere with study participation
  • Use of investigational products within 30 days prior to screening.
  • Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis
  • Receiving long-term antibiotic therapy
  • Received active or passive immunization within 4 weeks prior to Day
  • Pregnant or breastfeeding individuals

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: TP-05 (lotilaner) High Dose
Oral Tablet
Legemiddel: TP-05 (lotilaner) High Dose
TP05 administered orally at the protocol-defined preventative dose.
Placebo komparator: Placebo
Oral Tablet
Legemiddel: Placebo
Matching placebo administered orally according to the same dosing schedule as TP05.
Aktiv komparator: TP-05 (lotilaner) Low Dose
Oral Tablet
Legemiddel: TP-05 (lotilaner) Low Dose
TP05 administered orally at the protocol-defined preventative dose.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Incidence of Treatment Emergent Adverse Events From Baseline
Tidsramme: From day 1 through the end of study follow-up, an average of 15 months.
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
From day 1 through the end of study follow-up, an average of 15 months.
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Number of participants with clinically significant changes in clinical laboratory tests
From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Hematology Laboratory Tests
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Number of participants with clinically significant changes in clinical laboratory tests.
From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Vital Signs
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Number of participants with clinically significant changes in vital signs.
From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate [beats/min].
From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate [msec].
From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QTC Interval
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval
From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QRS Interval
Tidsramme: From day 1 through the end of study follow up, an average of 15 months.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.
From day 1 through the end of study follow up, an average of 15 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concentration of Lotilaner in Whole Blood
Tidsramme: From dose through study completion, an average of 15 months.
Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays.
From dose through study completion, an average of 15 months.
Terminal Elimination Half Life (t½) of Lotilaner
Tidsramme: At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Terminal elimination half life (t½) of lotilaner.
At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Area Under the Concentration Time Curve (AUC) of Lotilaner
Tidsramme: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Area under the concentration time curve (AUC) of lotilaner.
At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Maximum Observed Concentration (Cmax) of Lotilaner
Tidsramme: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Maximum observed concentration (Cmax) of lotilaner.
At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Time to Maximum Observed Concentration (Tmax) of Lotilaner
Tidsramme: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Time to maximum observed concentration (Tmax) of lotilaner.
At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.

Samarbeidspartnere og etterforskere

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

Sponsor

Tarsus Pharmaceuticals, Inc.

Samarbeidspartnere

PPD Development, LP

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)

9. mars 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

30. mars 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TRS-018

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

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