A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
NCT07562087 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700
Last updated 2026-05-20
Summary
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Conditions
Interventions
- DRUG
-
TP-05 (lotilaner) Low Dose
TP05 administered orally at the protocol-defined preventative dose.
- DRUG
-
TP-05 (lotilaner) High Dose
TP05 administered orally at the protocol-defined preventative dose.
- DRUG
-
Matching placebo administered orally according to the same dosing schedule as TP05.
Sponsors & Collaborators
-
PPD Development, LP
collaborator INDUSTRY -
Tarsus Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-09
- Primary Completion
- 2027-10-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Postexposure Prophylaxis With Single Dose Doxycycline for the Prevention of Tick-borne Relapsing Fever
NCT06045481 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
NCT01491607 ·Status: COMPLETED ·Phase: PHASE3
-
Understanding Typhoid Disease After Vaccination
NCT01405521 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
NCT05047601 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
The Uninfected Ixodes Scapularis Human Tick Challenge Model
NCT05965635 ·Status: COMPLETED ·Phase: NA
-
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
NCT07215520 ·Status: RECRUITING ·Phase: PHASE2
-
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
NCT00679172 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
NCT03014089 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus
NCT02935673 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
NCT03170609 ·Status: COMPLETED ·Phase: PHASE2
-
FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4)
NCT03867162 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of LY3074828 in Healthy Participants
NCT03748940 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older
NCT05501522 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
NCT00258947 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Reactogenicity, and Immunogenicity Trial of STX-S SARS-CoV-2 Vaccine in Adults
NCT07095231 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
First-in-Human Study Testing a New Antibody Treatment for Tick-Borne Encephalitis in Healthy Volunteers.
NCT07377253 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
NCT04955626 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age
NCT05995275 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evealuate Safety and Immunogenicity of TI-0010 SARS-CoV-2 Vaccine in Healthy Adults
NCT06205524 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
NCT01160172 ·Status: COMPLETED ·Phase: PHASE1
-
Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study
NCT00672035 ·Status: COMPLETED ·Phase: PHASE2
-
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
NCT04452318 ·Status: COMPLETED ·Phase: PHASE3
-
Recombinant Attenuated Salmonella Typhi Vaccine Vectors Producing Streptococcus Pneumoniae PspA
NCT01033409 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine
NCT05685953 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
NCT04990544 ·Status: UNKNOWN ·Phase: PHASE2