Clinical trial NCT06394518: Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Prosthetic Joints Infection (PJI)
Lead sponsor: TenNor Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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:

  1. Hematology: hemoglobin (HGB), white blood cell (WBC), absolute neutrophil count (ANC), or platelet count (PLT) \< the lower limit of normal (LLN).
  2. Liver function: aspartate aminotransferase (AST) \> the upper limit of normal (ULN), and/or alanine aminotransferase (ALT) \> ULN, and/or total bilirubin \> ULN.
  3. 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:

  1. Body temperature (ear) ≥ 37.5 ºC.
  2. Blood pressure \>140/90 mmHg, or \<90/60 mmHg.
  3. 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Day 1 to Day 14
measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
timeFrame: 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
measure: Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-last)
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2092
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: