Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT07051603
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.
Detailed Description:
This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of SAL0140 tablets in healthy Chinese adult participants. Part B is a randomized, open-label, single-dose, two-period, two-sequence, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of SAL0140 tablets in healthy Chinese adult participants. Part C is a randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of SAL0140 tablets in healthy Chinese adult participants.
Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study. Each participant can only participate in one dose group in any part of the study after dosing.
Study:
NCT07051603
Study Brief:
Protocol Section:
NCT07051603