Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160401
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-11-04
Brief Title:
Evaluation of Safety Tolerability PKPD and Metabolism of Single-Dose SingletineDC407 in Adults
Sponsor:
Guangzhou JOYO Pharma Co Ltd
Organization:
Guangzhou JOYO Pharma Co Ltd
Study Overview
Official Title:
Safety Tolerability and Pharmacokinetic Characteristics of SingletineDC407 in Healthy Adult Subjects After Single and Multiple Doses a Single-center Randomized Double-blind Placebo-controlled Phase 1 Trial
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety tolerability and pharmacokinetic characteristics of Singletine in healthy adult subjects The main questions it aims to answer are safety and tolerability of Singletine in healthy subjects the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics Participants will be treated with Singletine orally and safety and pharmacokinetic evaluations will be conducted according to the protocol
Detailed Description:
This study will be an double-blinded single-center phase I clinical trial After being informed about the study and potential risks all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry And then subjects will be administered for single-dose treatment or 7-day multiple-dose treatment and 9-day safety follow up after the last dose of treatment The safety and pharmacokinetic measures will be conducted according to the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None