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

Part of paid clinical trials in Pikesville, Maryland.

Sponsor
Tarsus Pharmaceuticals, Inc.
Study ID
NCT07562087
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • TP-05 (lotilaner) Low Dose — DRUG
    TP05 administered orally at the protocol-defined preventative dose.
  • TP-05 (lotilaner) High Dose — DRUG
    TP05 administered orally at the protocol-defined preventative dose.
  • Placebo — DRUG
    Matching placebo administered orally according to the same dosing schedule as TP05.

Study Details

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

Key Dates

First listed
May 1, 2026
Start date
Mar 9, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
722 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TP-05 (lotilaner) High Dose
    Oral Tablet
  • Placebo Comparator: Placebo
    Oral Tablet
  • Active Comparator: TP-05 (lotilaner) Low Dose
    Oral Tablet

Primary Outcome Measure

The Incidence of Treatment Emergent Adverse Events From Baseline [ Time Frame: From day 1 through the end of study follow-up, an average of 15 months. ]

Locations (19)

FacilityCityStateZIPSite coordinators
Study SitePikesvilleMaryland21208-
Study SiteBrooklineMassachusetts02445-
Study SiteFall RiverMassachusetts02723-
Study SiteMinneapolisMinnesota55402-
Study SiteMarlboroNew Jersey07746-
Study SiteAlbanyNew York12205-
Study SiteBinghamtonNew York13905-
Study SiteBuffaloNew York14217-
Study SiteEast SyracuseNew York13057-
Study SiteMiddletownNew York10941-
Study SiteNew YorkNew York10036-
Study SiteRochesterNew York14609-
Study SiteEriePennsylvania16508-
Study SiteHatboroPennsylvania19040-
Study SitePhiladelphiaPennsylvania19107-
Study SitePittsburghPennsylvania15236-
Study SitePottstownPennsylvania19464-
Study SiteWest ChesterPennsylvania19380-
Study SiteWarwickRhode Island02886-

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