CompletedPhase 1

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

China32 participantsStarted 2022-07-07

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. Body temperature (ear) ≥ 37.5 ºC.
✕. Blood pressure \>140/90 mmHg, or \<90/60 mmHg.
✕. Pulse rate \> 100 beat/min, or \< 50 beat/min.

What they're measuring

Percentage of Participants With Adverse Events (AEs)

Timeframe: Day 1 to Day 14

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

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

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

Trial details

NCT IDNCT06394518

SponsorTenNor Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-24

View on ClinicalTrials.gov More Acute Bacterial Skin and Skin Structure Infection (ABSSSI) trials

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. Body temperature (ear) ≥ 37.5 ºC.
✕. Blood pressure \>140/90 mmHg, or \<90/60 mmHg.
✕. Pulse rate \> 100 beat/min, or \< 50 beat/min.

What they're measuring

Percentage of Participants With Adverse Events (AEs)

Timeframe: Day 1 to Day 14

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

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

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