NCT06160401

Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in Adults

Safety, Tolerability and Pharmacokinetic Characteristics of Singletine(DC407) in Healthy Adult Subjects After Single and Multiple Doses: a Single-center, Randomized, Double-blind, Placebo-controlled, Phase 1 Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Guangzhou JOYO Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Singletine	Singletine orally administered
DRUG	Placebo	Placebo orally administered

Timeline

• Start date: 2020-08-18
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2023-12-07
• Last updated: 2023-12-07

Locations

1 site across 1 country: China