Lyme DiseasePhase 2NCT07562087
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
A Phase 2 study testing TP-05 (lotilaner) Low Dose and TP-05 (lotilaner) High Dose in people with Lyme Disease, run by Tarsus Pharmaceuticals, Inc. at 19 sites in United States.
Trial summary
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- TP-05 (lotilaner) Low Dose and TP-05 (lotilaner) High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 722 participants
- Where
- 19 sitesUnited States
- Study dates
- 9 Mar 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study Site
Albany, New York, 12205
Study Site
Binghamton, New York, 13905
Study Site
Brookline, Massachusetts, 02445
Study Site
Buffalo, New York, 14217
Study Site
East Syracuse, New York, 13057
Study Site
Erie, Pennsylvania, 16508
Study Site
Fall River, Massachusetts, 02723
Study Site
Hatboro, Pennsylvania, 19040
Study Site
Marlboro, New Jersey, 07746
Study Site
Middletown, New York, 10941
Study Site
Minneapolis, Minnesota, 55402
Study Site
New York, New York, 10036
Study Site
Philadelphia, Pennsylvania, 19107
Study Site
Pikesville, Maryland, 21208
Study Site
Pittsburgh, Pennsylvania, 15236
Study Site
Pottstown, Pennsylvania, 19464
Study Site
Rochester, New York, 14609
Study Site
Warwick, Rhode Island, 02886
Study Site
West Chester, Pennsylvania, 19380
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Lyme Disease
- Being tested
- TP-05 (lotilaner) Low Dose, TP-05 (lotilaner) High Dose, Placebo
- Keywords
- Lyme Disease, Lyme Borreliosis, Lyme, Borrelia, Preventative Therapeutic, Prophylaxis, Healthy Volunteers, Randomized Controlled Trial, Gram-Negative Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses, Infections, Borrelia Infections, Spirochaetales Infections, Tick-Borne Diseases, Vector Borne Diseases
- Medical subject headings
- Lyme Disease, Gram-Negative Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses, Infections, Borrelia Infections, Spirochaetales Infections, Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-05 (lotilaner) Low DoseDrug
TP05 administered orally at the protocol-defined preventative dose.
TP-05 (lotilaner) High DoseDrug
TP05 administered orally at the protocol-defined preventative dose.
PlaceboDrug
Matching placebo administered orally according to the same dosing schedule as TP05.
| Study group | Role | What they receive |
|---|---|---|
| TP-05 (lotilaner) High Dose | Active comparator | Oral Tablet Receives: Drug: TP-05 (lotilaner) High Dose |
| Placebo | Placebo comparator | Oral Tablet Receives: Drug: Placebo |
| TP-05 (lotilaner) Low Dose | Active comparator | Oral Tablet Receives: Drug: TP-05 (lotilaner) Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Treatment Emergent Adverse Events From Baseline
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Measured: From day 1 through the end of study follow-up, an average of 15 months.
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
Number of participants with clinically significant changes in clinical laboratory tests
Measured: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Hematology Laboratory Tests
Number of participants with clinically significant changes in clinical laboratory tests.
Measured: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Vital Signs
Number of participants with clinically significant changes in vital signs.
Measured: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate [beats/min].
Measured: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate [msec].
Measured: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QTC Interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval
Measured: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QRS Interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.
Measured: From day 1 through the end of study follow up, an average of 15 months.
Secondary outcomes (5)
Concentration of Lotilaner in Whole Blood
Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays.
Measured: From dose through study completion, an average of 15 months.
Terminal Elimination Half Life (t½) of Lotilaner
Terminal elimination half life (t½) of lotilaner.
Measured: At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Area Under the Concentration Time Curve (AUC) of Lotilaner
Area under the concentration time curve (AUC) of lotilaner.
Measured: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Maximum Observed Concentration (Cmax) of Lotilaner
Maximum observed concentration (Cmax) of lotilaner.
Measured: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Time to Maximum Observed Concentration (Tmax) of Lotilaner
Time to maximum observed concentration (Tmax) of lotilaner.
Measured: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start9 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562087
- Sponsor's protocol ID
- TRS-018
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07562087
- Acronym / sponsor ID
- TRS-018
- Conditions
- Lyme Disease
- Keywords
- Lyme Disease, Lyme Borreliosis, Lyme, Borrelia, Preventative Therapeutic, Prophylaxis, Healthy Volunteers, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TP-05 (lotilaner) High Dose | Active comparator | Drug: TP-05 (lotilaner) High DoseOral Tablet |
| Placebo | Placebo comparator | Drug: PlaceboOral Tablet |
| TP-05 (lotilaner) Low Dose | Active comparator | Drug: TP-05 (lotilaner) Low DoseOral Tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP-05 (lotilaner) Low DoseTP05 administered orally at the protocol-defined preventative dose. | Drug | TP-05 (lotilaner) Low Dose |
| TP-05 (lotilaner) High DoseTP05 administered orally at the protocol-defined preventative dose. | Drug | TP-05 (lotilaner) High Dose |
| PlaceboMatching placebo administered orally according to the same dosing schedule as TP05. | Drug | Placebo |
Primary outcome
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.
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
Time frame: 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
Clinically Significant Changes From Baseline Hematology Laboratory Tests
Time frame: 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.
Clinically Significant Changes From Baseline Vital Signs
Time frame: 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.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
Time frame: 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].
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
Time frame: 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].
Clinically Significant Changes From Baseline QTC Interval
Time frame: 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
Clinically Significant Changes From Baseline QRS Interval
Time frame: 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.
5 secondary outcomes
Concentration of Lotilaner in Whole Blood
Time frame: From dose through study completion, an average of 15 months.
Terminal Elimination Half Life (t½) of Lotilaner
Time frame: At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Area Under the Concentration Time Curve (AUC) of Lotilaner
Time frame: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Maximum Observed Concentration (Cmax) of Lotilaner
Time frame: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Time to Maximum Observed Concentration (Tmax) of Lotilaner
Time frame: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TP-05 (lotilaner) Low Dose and TP-05 (lotilaner) High Dose in people with Lyme Disease, run by Tarsus Pharmaceuticals, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.