A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants

NCT06081699 | Completed Phase 1 FDA Drug

• 1 other identifier: TNP-2198-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 4

Secondary Outcomes (3)

• Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)

  Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.

• Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)

  Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.

• Maximum Observed Plasma Concentration (Cmax) of TNP-2198

  Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.

Study Arms (9)

Single Ascending Doses Cohort 1

EXPERIMENTAL

TNP-2198 Capsules 50mg

Drug: TNP-2198

Single Ascending Doses Cohort 2

EXPERIMENTAL

TNP-2198 Capsules 100mg

Drug: TNP-2198

Single Ascending Doses Cohort 3

EXPERIMENTAL

TNP-2198 Capsules 200mg

Drug: TNP-2198

Single Ascending Doses Cohort 4

EXPERIMENTAL

TNP-2198 Capsules 400mg

Drug: TNP-2198

Single Ascending Doses Cohort 5

EXPERIMENTAL

TNP-2198 Capsules 600mg

Drug: TNP-2198

Single Ascending Doses Cohort 6

EXPERIMENTAL

TNP-2198 Capsules 800mg

Drug: TNP-2198

Single Ascending Doses Cohort 7

EXPERIMENTAL

TNP-2198 Capsules 1000mg

Drug: TNP-2198

Food Effect Cohort 8

EXPERIMENTAL

TNP-2198 Capsules 200mg

Drug: TNP-2198

Placebo Cohort 9

PLACEBO COMPARATOR

Placebo

Drug: TNP-2198 Placebo

Interventions

TNP-2198 DRUG

Oral

Also known as: Rifasutenizol

Food Effect Cohort 8; Single Ascending Doses Cohort 1; Single Ascending Doses Cohort 2; Single Ascending Doses Cohort 3; Single Ascending Doses Cohort 4; Single Ascending Doses Cohort 5; Single Ascending Doses Cohort 6; Single Ascending Doses Cohort 7

TNP-2198 Placebo DRUG

The placebo for TNP-2198 active drug

Placebo Cohort 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those signed the informed consent form and fully understood the study contents, process and possible adverse reactions before participation in the study;
• Those are able to complete the study according to the requirements of the study protocol;
• Those (including the partner) are willing to use effective contraceptives from the screening up to 6 months after the last dose of study drug;
• Male and female subjects aged 18 to 55 years (inclusive);
• Male subjects no less than 50 kg and female subjects no less than 45 kg. BMI (Body Mass Index= body weight (kg)/height\^2 (m\^2)): 18-28kg/m\^2 (inclusive);
• Health status: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities;
• Normal results or abnormal results without clinical significance in physical examinations and vital signs;
• Clinical laboratory test results are within normal limits or abnormal but without clinical significance as judged by the investigator.

You may not qualify if:

• Average daily consumption of more than 5 cigarettes within 3 months before the study;
• History of hypersensitivity to study drug or its excipients, or allergic constitution (allergy to multiple drugs and food);
• History of drug and/or alcohol abuse (mean consumption of ≥ 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine);
• Blood donation or massive blood loss (\> 450 mL) within 3 months prior to screening;
• Using any drug that changes liver enzyme activity within 28 days prior to screening;
• Using any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine within 14 days prior to screening;
• Taking special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, or having other factors that affect drug absorption, distribution, metabolism, excretion, etc., within 2 weeks prior to screening;
• Significant changes in diet or exercise habits recently;
• Taking other study drugs or participating in other clinical studies within 3 months before taking the study drug;
• With difficulty in swallowing or history of any gastrointestinal diseases that affect drug absorption;
• With any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
• Unable to tolerate standardized meal (two boiled eggs, one butter bacon toast, one box of fried potato chips, and one cup of whole milk) (only for subjects participating in the food effect study);
• With clinically significant ECG abnormalities;
• Female subjects who are lactating or have positive serum pregnancy result during the screening period, or have positive serum pregnancy result during the study;
• With symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases, tumor, or psychiatric diseases;

Sponsors & Collaborators

• TenNor Therapeutics (Suzhou) Limited: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.

  PMID: 38359854 DERIVED

Study Officials

• TenNor Clinical Trials

  TenNor

  STUDY DIRECTOR

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: September 22, 2023
• First Posted: October 13, 2023
• Study Start: May 9, 2019
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)