Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants

NCT06394518 | Completed Phase 1 FDA Drug

• 1 other identifier: TNP-2092-IV-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Prosthetic Joints Infection (PJI)

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  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

Study Arms (4)

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).

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.

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)

Drug: TNP-2092 for injection; Drug: placebo

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

TNP-2092 for injection DRUG

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)

Also known as: Rifaquizinone

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 DRUG

The placebo for TNP-2092 active 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• TenNor Therapeutics Inc.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

TNP-2092; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: July 7, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)