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

Phase 1 Completed 20 enrolled South China Center For Innovative Pharmaceuticals Xiangya Hospital of Central South University · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2020-05-26
Primary completion: 2020-07-31
Completion: 2020-07-31

Publications

Peng D, Xu S, Zou T, Wang Y, Ouyang W, Zhang Y, Dong C, Li D, Guo J, Shen Q, Hu X, Zhou W, Li X, Qin Q. Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. BMC Med. 2023 Nov 23;21(1):459. doi: 10.1186/s12916-023-03126-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AD16	Unknown	30 mg	Oral
Subject	AD16	Unknown	40 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications