NCT05806177

Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects

Safety, Tolerability and Pharmacokinetics of AD16 Tablets After Multiple Administration in Healthy Chinese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: South China Center For Innovative Pharmaceuticals · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This single-center, randomized, placebo-controlled, double-blind, dose-increasing study was designed to evaluate the safety, tolerability, and pharmacokinetics of multiple successive dosing in healthy Chinese adult subjects.In this study, 20 healthy adult subjects were enrolled in a multi-dose study in the 30mg and 40mg groups.

Detailed description

In this study, subjects were given multiple doses in the corresponding dose group

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	AD16 30mg、40mg	AD16 was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study
DRUG	AD16 Placebo 30mg、40mg	AD16 placebo was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study

Timeline

• Start date: 2020-05-26
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2023-04-10
• Last updated: 2023-12-01

Locations

1 site across 1 country: China