Periprosthetic Joint Infection (PJI)Phase 1/2NCT06889701
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
A Phase 1/2 study testing TNP-2092 for injection, Vancomycin Hydrochloride for Injection (IA) and Vancomycin Hydrochloride for Injection (IV) in people with Periprosthetic Joint Infection (PJI), run by TenNor Therapeutics Inc. at 1 site in China.
Trial summary
This is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and oral antibiotics therapy in participants with early (within 1 month of TKA) or acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection (PJI)
- What is being tested?
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection (IA) and Vancomycin Hydrochloride for Injection (IV)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to Jan 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requires or does not require DAIR therapy after TKA, or results of treatment for PJI (including PJI occurring after various joint replacements and revision surgeries) did not meet the clinical cure criteria and requiring long-term antibiotic suppression therapy as judged by investigators before enrollment.
- Suspected or confirmed PJI was caused by a Gram-positive bacterial infection, including methicillin-resistant and ciprofloxacin-resistant Staphylococcus aureus and Staphylococcus epidermidis, as judged by the investigator.
- Agree to be hospitalized for 2 weeks with local intra-articular injection.
- 18 years of age or older (of either sex) at the time of signing the informed consent form (ICF).
- The implanted prosthetic joint was well fixed.
- No sinus tract that communicates with the prosthesis.
- Body mass index (BMI) ≥ 18 kg/m^2 and ≤ 34 kg/m^2.
- Agree to voluntarily use effective contraception from signing the ICF through 8 weeks after the last dose of investigational product (in case of premature withdrawal from the study) or through completion of the end-of-study visit. Male participants must refrain from donating sperm during this period.
Who cannot join
- History of hypersensitivity or intolerance to any of the following agents: vancomycin or TNP-2092.
- Definite PJI of Gram-negative infection, fungal infection, or Enterococcus infection, or Mycobacterium infection, or Gram-positive mixed Gram-negative and/or fungal infection.
- Definite systemic infection (sepsis).
- Expected survival less than 1 years.
- Female participant is pregnant, lactating, or has a positive screening/baseline pregnancy test.
- Surgical or medical conditions that, in the opinion of the investigator, could affect the participant's ability to participate in the study, or affect the administration of investigational product, or affect the interpretation of study results, including but not limited to active malignancy, metabolic disease, alcohol or drug abuse, or clinically significant laboratory abnormalities.
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- Presence of serious liver, blood, or immune system disorders as evidenced by the following:
- Acute hepatitis of any cause within the past year.
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > 2 times the upper limit of normal (ULN).
- Presence of end-stage liver disease-related manifestations such as ascites or hepatic encephalopathy.
- Current or anticipated neutropenia (ie, neutrophil count < 0.5 x 10^9/L).
- Chemotherapy for cancer, radiation therapy, or potent noncorticosteroid immunosuppressants (eg, cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc) within the past 3 months or corticosteroids (≥ 40 mg prednisone/day) for more than 14 days within 30 days prior to randomization.
- Positive AIDS antibody screening.
- History or evidence of severe renal disease or creatinine clearance < 30 mL/min based on the Cockcroft-Gault formula.
- Treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Participants who, in the opinion of the investigator, were unable to comply with the protocol and study drug administration procedures or complete the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Li Cao, +86 991-4366553, xjbone@sina.com
About this study
Official title: A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in Participants With Early or Acute Hematogenous PJI Requiring or Not Requiring DAIR After TKA, or Requiring Long-term Antibiotic Therapy
This is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and oral antibiotics therapy in participants with early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacements and revision surgeries).
Read the detailed description
The study population is participants with confirmed or suspected Gram-positive bacteria causing early (ie, within 1 month of TKA) or acute hematogenous (within 3 weeks of infection symptoms) PJI requiring or not requiring DAIR therapy following TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacement and revision surgeries). Participants will undergo screening assessments within 7 days prior to study start.
- Conditions
- Periprosthetic Joint Infection (PJI)
- Being tested
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection (IA), Vancomycin Hydrochloride for Injection (IV), Oral antibiotics, Background Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNP-2092 for injectionDrug
Also called rifaquizinone for injection
TNP-2092 for injection, 100 mg/vial, Intra-articular administration (IA), 10ml (50 mg) once daily for 14 days. TNP-2092 dose volume, dose, frequency, and duration can be adjusted according to the sentinel group synovial fluid TNP-2092 concentration, PK characteristics, and safety results at the EA visit.
Vancomycin Hydrochloride for Injection (IA)Drug
Vancomycin Hydrochloride for Injection, 0.5 g/vial, Intra-articular administration, 10 mL (0.5 g) once daily for 14 days.
Vancomycin Hydrochloride for Injection (IV)Drug
Vancomycin Hydrochloride for Injection, 0.5 g/vial, Intravenous infusion, 250 mL (1 g) q12h ± 1h per day, for 14 days.
Oral antibioticsDrug
Rifampicin capsules: 0.15 g/capsule. 0.45 g (3 capsules) orally once daily within 1 h before breakfast for 8 weeks (56 days).
Levofloxacin Tablets: 0.5 g/tablet. 0.5 g (1 tablet) orally once daily within 1 hour before breakfast for 8 weeks (56 days).
If susceptibility testing results show resistance to rifampicin and/or levofloxacin, or intolerance by the patient 's participant, treatment with oral minocycline hydrochloride capsules will be substituted as follows:Minocycline hydrochloride capsules: 100 mg/capsule. Administered orally q12h ± 1h daily, doubling the first dose, 200 mg (2 capsules) orally, then 100 mg (1 capsule) each time for 8 weeks (56 days).
The total duration of oral treatment during the oral administration period was 8 weeks (56 days) regardless of whether oral medication will be changed (eg, intolerance).
Background TreatmentDrug
Background treatment will be determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel group | Experimental | In the sentinel group, participants will receive TNP-2092 50 mg IA+vancomycin IV+oral antibiotics. Receives: Drug: TNP-2092 for injection; Drug: Vancomycin Hydrochloride for Injection (IV); Drug: Oral antibiotics |
| Experimental group | Experimental | In the experimental group, participants will receive TNP-2092 50 mg IA + vancomycin IV + oral antibiotics. Receives: Drug: TNP-2092 for injection; Drug: Vancomycin Hydrochloride for Injection (IV); Drug: Oral antibiotics |
| Control group | Active comparator | In the control group, participants will receive vancomycin IA + vancomycin IV + oral antibiotics. Receives: Drug: Vancomycin Hydrochloride for Injection (IA); Drug: Vancomycin Hydrochloride for Injection (IV); Drug: Oral antibiotics |
| Expansion group | Experimental | In the expansion group, participants will receive TNP-2092 50 mg IA based on the background treatment. Receives: Drug: TNP-2092 for injection; Drug: Background Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of TNP-2092 by Assessment of the Number of Adverse Events (AEs)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Measured: Day 1 to Day 187
Secondary outcomes (16)
TNP-2092 concentrations in synovial fluid
Synovial fluid concentrations of TNP-2092 were measured by a specific and validated assay.
Measured: At 12, 24 hours after the first dose of TNP-2092, before dosing on Day 7, before the last dose, and at 12, 24, 48 hours after the last dose.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 after the first dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) after the first dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Area under the curve from the time of dosing to the last measurable concentration (AUC 0-t) after the first dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Area under the curve from the time of dosing to infinity (AUC 0-∞) after the first dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Elimination half-life (t 1/2) after the first dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Maximum observed concentration at steady state (Cmax, ss) after the last dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Time to maximum concentration at steady state (Tmax, ss) after the last dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Area under the curve from the time of dosing to the last measurable concentration at steady state (AUC 0-t, ss) after the last dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Area under the curve from the time of dosing to infinity at steady state (AUC 0-∞, ss) after the last dose
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Area under the curve over the dosing interval at steady state (AUC 0-tau, ss)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24 hours after the last dose
Elimination half-life at steady state (t 1/2, ss)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Accumulation ratio (Rac)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Before administration (within 1 hour) of the first dose, 1, 4, 12, 24 hours after the first dose; Before administration (within 1 hour) of the last dose, 1, 4, 12, 24 hours after the last dose
Early Assessment (EA) response rate
Participants with early or acute hematogenous PJI after TKA who met all the following criteria will be judged as responders:
- At least 2 body temperature measurements within the last 24 hours separated by more than 6 hours were ≤ 37.6ºC.
- Peripheral white blood cell (WBC) count returned to normal range (as determined by local laboratory reference range).
- Synovial fluid WBC < 3000 cell/μL and polymorphonuclear leukocytes percentage (PMN%) < 80%.
- Inflammatory manifestations (pain, erythema, edema, wound exudate) at the primary infection site resolved, with pain requiring resolution or tolerance.
- Inflammatory markers (ie, C-reactive protein [CRP]) improved to 50% of normal or baseline values.
Measured: Day 14
End of treatment (EOT) response rate
Participants who met all the following criteria were judged as responders:
- Joint pain resolved or tolerated.
- Joint function improvement.
- Inflammatory markers (ie, CRP) returned to ≤ 10 mg/L.
Measured: Day 71 to Day 77
Treatment failure rate
Those who meet any of the following criteria are treatment failures:
- No response at EA assessment (only for participants with early or acute hematogenous PJI after TKA).
- No response at EOT assessment.
- Receiving systemic antibiotics for infected joints after the end of study treatment.
- Additional surgical treatment of infected joints is required during the study.
- Death due to primary joint infection.
Measured: Within 6 months and 12 months after the start of study treatment, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start3 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint Infection (PJI)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three eligible participants will be enrolled as sentinel group. After all sentinel participants are tolerable safety at EA assessment and complete the PK study, an additional 20 participants will be enrolled and randomize in 1:1 ratio to the experimental group and the control group. Ten subjects requiring long-term suppressive antibiotic therapy for PJI (including PJI occurring after various joint replacement surgeries) will be enrolled in the expansion group and could be enrolled in parallel with the sentinel group.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889701
- Sponsor's protocol ID
- TNP-2092-IA-01
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2025
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in Participants With Early or Acute Hematogenous PJI Requiring or Not Requiring DAIR After TKA, or Requiring Long-term Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT06889701
- Acronym / sponsor ID
- TNP-2092-IA-01
- Conditions
- Periprosthetic Joint Infection (PJI)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- TenNor Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Mar 2025 (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 is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and oral antibiotics therapy in participants with early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacements and revision surgeries).
Detailed description
The study population is participants with confirmed or suspected Gram-positive bacteria causing early (ie, within 1 month of TKA) or acute hematogenous (within 3 weeks of infection symptoms) PJI requiring or not requiring DAIR therapy following TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacement and revision surgeries). Participants will undergo screening assessments within 7 days prior to study start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Three eligible participants will be enrolled as sentinel group. After all sentinel participants are tolerable safety at EA assessment and complete the PK study, an additional 20 participants will be enrolled and randomize in 1:1 ratio to the experimental group and the control group. Ten subjects requiring long-term suppressive antibiotic therapy for PJI (including PJI occurring after various joint replacement surgeries) will be enrolled in the expansion group and could be enrolled in parallel with the sentinel group.
| Arm | Type | Receives |
|---|---|---|
| Sentinel group | Experimental | Drug: TNP-2092 for injection, Drug: Vancomycin Hydrochloride for Injection (IV), Drug: Oral antibioticsIn the sentinel group, participants will receive TNP-2092 50 mg IA+vancomycin IV+oral antibiotics. |
| Experimental group | Experimental | Drug: TNP-2092 for injection, Drug: Vancomycin Hydrochloride for Injection (IV), Drug: Oral antibioticsIn the experimental group, participants will receive TNP-2092 50 mg IA + vancomycin IV + oral antibiotics. |
| Control group | Active comparator | Drug: Vancomycin Hydrochloride for Injection (IA), Drug: Vancomycin Hydrochloride for Injection (IV), Drug: Oral antibioticsIn the control group, participants will receive vancomycin IA + vancomycin IV + oral antibiotics. |
| Expansion group | Experimental | Drug: TNP-2092 for injection, Drug: Background TreatmentIn the expansion group, participants will receive TNP-2092 50 mg IA based on the background treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requires or does not require DAIR therapy after TKA, or results of treatment for PJI (including PJI occurring after various joint replacements and revision surgeries) did not meet the clinical cure criteria and requiring long-term antibiotic suppression therapy as judged by investigators before enrollment.
- Suspected or confirmed PJI was caused by a Gram-positive bacterial infection, including methicillin-resistant and ciprofloxacin-resistant Staphylococcus aureus and Staphylococcus epidermidis, as judged by the investigator.
- Agree to be hospitalized for 2 weeks with local intra-articular injection.
- 18 years of age or older (of either sex) at the time of signing the informed consent form (ICF).
- The implanted prosthetic joint was well fixed.
Key exclusion criteria (16 listed)
- History of hypersensitivity or intolerance to any of the following agents: vancomycin or TNP-2092.
- Definite PJI of Gram-negative infection, fungal infection, or Enterococcus infection, or Mycobacterium infection, or Gram-positive mixed Gram-negative and/or fungal infection.
- Definite systemic infection (sepsis).
- Expected survival less than 1 years.
- Female participant is pregnant, lactating, or has a positive screening/baseline pregnancy test.
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 |
|---|---|---|
| TNP-2092 for injectionAlso: rifaquizinone for injectionTNP-2092 for injection, 100 mg/vial, Intra-articular administration (IA), 10ml (50 mg) once daily for 14 days. TNP-2092 dose volume, dose, frequency, and duration can be adjusted according to the sentinel group synovial fluid TNP-2092 concentration, PK characteristics, and safety results at the EA visit. | Drug | Expansion group, Experimental group, Sentinel group |
| Vancomycin Hydrochloride for Injection (IA)Vancomycin Hydrochloride for Injection, 0.5 g/vial, Intra-articular administration, 10 mL (0.5 g) once daily for 14 days. | Drug | Control group |
| Vancomycin Hydrochloride for Injection (IV)Vancomycin Hydrochloride for Injection, 0.5 g/vial, Intravenous infusion, 250 mL (1 g) q12h ± 1h per day, for 14 days. | Drug | Control group, Experimental group, Sentinel group |
| Oral antibioticsRifampicin capsules: 0.15 g/capsule. 0.45 g (3 capsules) orally once daily within 1 h before breakfast for 8 weeks (56 days). Levofloxacin Tablets: 0.5 g/tablet. 0.5 g (1 tablet) orally once daily within 1 hour before breakfast for 8 weeks (56 days). If susceptibility testing results show resistance to rifampicin and/or levofloxacin, or intolerance by the patient 's participant, treatment with oral minocycline hydrochloride capsules will be substituted as follows:Minocycline hydrochloride capsules: 100 mg/capsule. Administered orally q12h ± 1h daily, doubling the first dose, 200 mg (2 capsules) orally, then 100 mg (1 capsule) each time for 8 weeks (56 days). The total duration of oral treatment during the oral administration period was 8 weeks (56 days) regardless of whether oral medication will be changed (eg, intolerance). | Drug | Control group, Experimental group, Sentinel group |
| Background TreatmentBackground treatment will be determined by the investigator. | Drug | Expansion group |
Primary outcome
Safety and Tolerability of TNP-2092 by Assessment of the Number of Adverse Events (AEs)
Time frame: Day 1 to Day 187
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
16 secondary outcomes
TNP-2092 concentrations in synovial fluid
Time frame: At 12, 24 hours after the first dose of TNP-2092, before dosing on Day 7, before the last dose, and at 12, 24, 48 hours after the last dose.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 after the first dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) after the first dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Area under the curve from the time of dosing to the last measurable concentration (AUC 0-t) after the first dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Area under the curve from the time of dosing to infinity (AUC 0-∞) after the first dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Elimination half-life (t 1/2) after the first dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24 hours after the first dose
Maximum observed concentration at steady state (Cmax, ss) after the last dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Time to maximum concentration at steady state (Tmax, ss) after the last dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Area under the curve from the time of dosing to the last measurable concentration at steady state (AUC 0-t, ss) after the last dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Area under the curve from the time of dosing to infinity at steady state (AUC 0-∞, ss) after the last dose
Time frame: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Area under the curve over the dosing interval at steady state (AUC 0-tau, ss)
Time frame: Before administration (within 1 hour), 1, 4, 12, 24 hours after the last dose
Elimination half-life at steady state (t 1/2, ss)
Time frame: Before administration (within 1 hour), 1, 4, 12, 24, 48 hours after the last dose
Accumulation ratio (Rac)
Time frame: Before administration (within 1 hour) of the first dose, 1, 4, 12, 24 hours after the first dose; Before administration (within 1 hour) of the last dose, 1, 4, 12, 24 hours after the last dose
Early Assessment (EA) response rate
Time frame: Day 14
End of treatment (EOT) response rate
Time frame: Day 71 to Day 77
Treatment failure rate
Time frame: Within 6 months and 12 months after the start of study treatment, respectively
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 19 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNP-2092 for injection, Vancomycin Hydrochloride for Injection (IA) and Vancomycin Hydrochloride for Injection (IV) in people with Periprosthetic Joint Infection (PJI), run by TenNor Therapeutics Inc. at 1 site in China.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Li Cao (+86 991-4366553, xjbone@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of TNP-2092 by Assessment of the Number of Adverse Events (AEs) (time frame: Day 1 to Day 187). 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 19 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.