A Phase 1 interventional study of TNP-2198 and TNP-2198 Placebo in Helicobacter Pylori Infection, sponsored by TenNor Therapeutics (Suzhou) Limited. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by TenNor Therapeutics (Suzhou) Limited · Phase 1, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 48 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →TenNor Therapeutics (Suzhou) Limited is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TNP-2198 Capsules 200mg, BID, for 14days
Drug: TNP-2198 · Drug: TNP-2198 Placebo
TNP-2198 Capsules 400mg,BID, for 14days
Drug: TNP-2198 · Drug: TNP-2198 Placebo
TNP-2198 Capsules 600mg,BID, for 14days
Drug: TNP-2198 · Drug: TNP-2198 Placebo
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
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.
Incidence of Adverse Events(AEs)
The percentage of subjects with at least one AEs.
Time frame: up to 17 days
Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞)
Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Time frame: 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)
Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma PK parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Time frame: 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
Plasma concentrations of TNP-2198 were measured by a specific and validated assay at specified time points
Time frame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15
Plan to share: No
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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TenNor Therapeutics (Suzhou) Limited