Acute Bacterial Skin and Skin Structure Infection (ABSSSI)Phase 1NCT06394518
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
A Phase 1 study testing TNP-2092 for injection in people with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and Prosthetic Joints Infection (PJI), run by TenNor Therapeutics Inc. at 1 site in China.
Trial summary
This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Prosthetic Joints Infection (PJI)
- What is being tested?
- TNP-2092 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2022to 24 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eighteen to 45 years of age, inclusive, of either gender.
- A body weight of at least 50 kg (male participants) or 45 kg (female participants). A Body Mass Index (BMI) of between 18 to 28 kg/m2, inclusive.
- Physical examinations, vital signs, and clinical laboratory tests are normal, or non-clinically significant abnormal judged by Investigator.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- History or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise subject safety.
- History or presence of alcohol or drug abuse, or illegal drug use.
- Loss or donation of blood (> 450 mL) within 3 months prior to the start of the Screening Period.
- Any history of allergic drug reactions, or any contraindication to the use of rifampin/rifamycin or a fluoroquinolone.
- Taking any medication known to induce or inhibit CYP enzymes within 28 days prior to screening.
- Taking any prescribed or over-the-counter medications within 2 weeks prior to screening, or during the trial, including vitamins, food supplements, herbal remedies, or traditional Chinese remedies.
Show all 26Show fewer
- Significant abnormal findings on clinical laboratory tests, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety, including but not limited to:
- Hematology: hemoglobin (HGB), white blood cell (WBC), absolute neutrophil count (ANC), or platelet count (PLT) < the lower limit of normal (LLN).
- Liver function: aspartate aminotransferase (AST) > the upper limit of normal (ULN), and/or alanine aminotransferase (ALT) > ULN, and/or total bilirubin > ULN.
- Renal function: serum creatinine > ULN.
- Tests positive for the human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, and/or urine drug screening.
- Abnormal findings on vital signs, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety, including but not limited to:
- Body temperature (ear) ≥ 37.5 ºC.
- Blood pressure >140/90 mmHg, or <90/60 mmHg.
- Pulse rate > 100 beat/min, or < 50 beat/min.
- Abnormal findings on CT scan of chest and abdominal ultrasonography, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety.
- Any ECG abnormality considered to be clinically significant by the Investigator, or QTcF interval (QT interval corrected for heart rate per Fridericia's formula) > 450 msec.
- Abnormal findings on physical examination, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety.
- Smoking, or consuming coffee, tea, cola, chocolate, grapefruit/grapefruit juice, or alcohol within 48 hours prior to the first dose of the study drug.
- Use of ≥ 5 cigarettes per day within 3 months prior to screening. Participants may not smoking during the study.
- Consume ≥ 14 units of alcohol (1 unit = 285 mL beer, or 25 mL hard liquor/spirits, or 100 mL wine) per week within 6 months prior to screening; or cannot stop consumption of alcohol during the study.
- Received any investigational medication or participated any clinical study within 3 months prior to signing ICF.
- If female, the participant is pregnant, lactating, or serum pregnancy test positive during the screening.
- Cannot abstinence or effective methods of birth control, including his/her partner, during the study and within 12 weeks after the last dose of study drug.
- Venous access considered inadequate for PK sample collection; history or evidence of adverse symptoms associated with phlebotomy or blood donation.
- Any other reason that, in the opinion of the Investigator, would render the subject unsuitable for study enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.
- Conditions
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Prosthetic Joints Infection (PJI)
- Being tested
- TNP-2092 for injection, placebo
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
The study had 3 dose groups, a 200 mg single dose group (low-dose group), a 300 mg single and multiple dose continuous dose group (medium-dose group), and 400 mg single dose group (high-dose group)
placeboDrug
The placebo for TNP-2092 active drug
| Study group | Role | What they receive |
|---|---|---|
| 200 mg single dose group (low-dose group) | Experimental | Participants in the single-dose groups (200 mg in the low-dose group) were enrolled and received a single intravenous infusion of TNP-2092 for injection(Day 1) over 60 min (± 1 0 min). Receives: Drug: TNP-2092 for injection; Drug: placebo |
| 300 mg single and multiple dose continuous dose group (medium-dose group) | Experimental | Participants in the single-dose, multiple-dose continuous dosing group (300 mg in the medium-dose group) received a single intravenous infusion of TNP-2092 for injection on Day 1 of the study. Subsequently, TNP-2092 for injection or placebo was administered as an intravenous infusion every 12 hours (q12 h, ± 10 min) daily on Study Days 4 to 10, and the last dose of TNP-2092 for injection was administered on the morning of Study Day 11. Receives: Drug: TNP-2092 for injection; Drug: placebo |
| 400 mg single dose group (high-dose group) | Experimental | Participants in the single-dose groups (400 mg in the high-dose group) were enrolled and received a single intravenous infusion of TNP-2092 for injection over 60 min (± 1 0 min) Receives: Drug: TNP-2092 for injection; Drug: placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Measured: Day 1 to Day 14
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma pharmacokinetic(PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: 10, 20, 30, 45 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72 hours after the end of infusion
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-last)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: 10, 20, 30, 45 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72 hours after the end of infusion
Maximum Observed Plasma Concentration (Cmax) of TNP-2092
Plasma concentrations of TNP-2092 were measured by a specific and validated assay at specified time points
Measured: 10, 20, 30, 45 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72 hours after the end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start7 Jul 2022
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394518
- Sponsor's protocol ID
- TNP-2092-IV-09
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT06394518
- Acronym / sponsor ID
- TNP-2092-IV-09
- Conditions
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Prosthetic Joints Infection (PJI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TenNor Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 1 May 2024 (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, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200 mg single dose group (low-dose group) | Experimental | Drug: TNP-2092 for injection, Drug: placeboParticipants in the single-dose groups (200 mg in the low-dose group) were enrolled and received a single intravenous infusion of TNP-2092 for injection(Day 1) over 60 min (± 1 0 min). |
| 300 mg single and multiple dose continuous dose group (medium-dose group) | Experimental | Drug: TNP-2092 for injection, Drug: placeboParticipants in the single-dose, multiple-dose continuous dosing group (300 mg in the medium-dose group) received a single intravenous infusion of TNP-2092 for injection on Day 1 of the study. Subsequently, TNP-2092 for injection or placebo was administered as an intravenous infusion every 12 hours (q12 h, ± 10 min) daily on Study Days 4 to 10, and the last dose of TNP-2092 for injection was administered on the morning of Study Day 11. |
| 400 mg single dose group (high-dose group) | Experimental | Drug: TNP-2092 for injection, Drug: placeboParticipants in the single-dose groups (400 mg in the high-dose group) were enrolled and received a single intravenous infusion of TNP-2092 for injection over 60 min (± 1 0 min) |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Eighteen to 45 years of age, inclusive, of either gender.
- A body weight of at least 50 kg (male participants) or 45 kg (female participants). A Body Mass Index (BMI) of between 18 to 28 kg/m2, inclusive.
- Physical examinations, vital signs, and clinical laboratory tests are normal, or non-clinically significant abnormal judged by Investigator.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (26 listed)
- History or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise subject safety.
- History or presence of alcohol or drug abuse, or illegal drug use.
- Loss or donation of blood (> 450 mL) within 3 months prior to the start of the Screening Period.
- Any history of allergic drug reactions, or any contraindication to the use of rifampin/rifamycin or a fluoroquinolone.
- Taking any medication known to induce or inhibit CYP enzymes within 28 days prior to screening.
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: RifaquizinoneThe study had 3 dose groups, a 200 mg single dose group (low-dose group), a 300 mg single and multiple dose continuous dose group (medium-dose group), and 400 mg single dose group (high-dose group) | Drug | 200 mg single dose group (low-dose group), 300 mg single and multiple dose continuous dose group (medium-dose group), 400 mg single dose group (high-dose group) |
| placeboThe placebo for TNP-2092 active drug | Drug | 200 mg single dose group (low-dose group), 300 mg single and multiple dose continuous dose group (medium-dose group), 400 mg single dose group (high-dose group), Placebo |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Day 1 to Day 14
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: 10, 20, 30, 45 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72 hours after the end of infusion
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma pharmacokinetic(PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-last)
Time frame: 10, 20, 30, 45 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72 hours after the end of infusion
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092
Time frame: 10, 20, 30, 45 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72 hours after the end of infusion
Plasma concentrations of TNP-2092 were measured by a specific and validated assay at specified time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNP-2092 for injection in people with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and Prosthetic Joints 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 4 inclusion and 26 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: finished, as of the sponsor's last update on 1 May 2024. 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants With Adverse Events (AEs) (time frame: Day 1 to Day 14). The study lists 4 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 1 May 2024.