A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection

NCT06081712 | Completed Phase 1 FDA Drug

• 1 other identifier: TNP-2198-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy of TNP-2198 capsules.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events(AEs)

  The percentage of subjects with at least one AEs.

  up to 17 days

Secondary Outcomes (3)

• Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞)

  Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15

• Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last)

  Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15

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

  Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15

Study Arms (3)

Multiple Ascending Doses Cohort 1

EXPERIMENTAL

TNP-2198 Capsules 200mg, BID, for 14days

Drug: TNP-2198; Drug: TNP-2198 Placebo

Multiple Ascending Doses Cohort 2

EXPERIMENTAL

TNP-2198 Capsules 400mg,BID, for 14days

Drug: TNP-2198; Drug: TNP-2198 Placebo

Multiple Ascending Doses Cohort 3

EXPERIMENTAL

TNP-2198 Capsules 600mg,BID, for 14days

Drug: TNP-2198; Drug: TNP-2198 Placebo

Interventions

TNP-2198 DRUG

TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

Also known as: Rifasutenizol

Multiple Ascending Doses Cohort 1; Multiple Ascending Doses Cohort 2; Multiple Ascending Doses Cohort 3

TNP-2198 Placebo DRUG

TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

Multiple Ascending Doses Cohort 1; Multiple Ascending Doses Cohort 2; Multiple Ascending Doses Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• 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 in the study protocol;
• Those (including the partner) are willing to use effective contraceptions from the screening up to 6 months after the last dose of study drug;
• Male and female subjects aged 18-55 years (inclusive);
• Male subjects no less than 50 kg and female subjects no less than 45 kg. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI: 18-28kg/m2 (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 clinically insignificant abnormal results in physical examinations and vital sign assessment;
• Positive result of 14C urea breath test (UBT).

You may not qualify if:

• Average daily consumption of more than 5 cigarettes within 3 months before the study;
• 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);
• History of Helicobacter Pylori eradication;
• 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;
• Administration of any other study drug or participation in any drug clinical study within 3 months before administration of 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;
• With clinically significant ECG abnormalities;
• Female subjects who are lactating or having positive serum pregnancy test during screening or 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 25, 2023
• First Posted: October 13, 2023
• Study Start: October 20, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)