NCT05787028

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: South China Center For Innovative Pharmaceuticals · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults under fasting conditions, and the secondary objective was to preliminarily evaluate the material balance of single administration of AD16 tablets in fasting conditions. The study is divided into two parts: preliminary test and formal test. The formal trial was a single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5 dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively). Ten subjects (male and female) were enrolled in each dose group, of which 8 received the experimental drug and 2 received placebo. Urine and fecal samples were collected in the 20mg dose group for material balance study.Urine and fecal samples were collected in the 20mg dose group for material balance study.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg	Take one AD16 tablet in the morning
DRUG	AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg	Participants will take a placebo pill matching AD16 once in the morning

Timeline

• Start date: 2019-01-30
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2023-03-28
• Last updated: 2023-12-01

Locations

1 site across 1 country: China