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NCT05806177: MAD

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

Completed Phase 1 Last updated 1 December 2023
What this trial tests

Phase 1 trial testing AD16 30mg、40mg in Alzheimer Disease in 20 participants. Completed in 31 July 2020.

Timeline
26 May 2020
Primary endpoint
31 July 2020
31 July 2020

Quick facts

Lead sponsorSouth China Center For Innovative Pharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment20
Start date26 May 2020
Primary completion31 July 2020
Estimated completion31 July 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

South China Center For Innovative Pharmaceuticals — full company profile →

Who can join

Adults 18 to 45, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study.
    Peng D, Xu S, Zou T, Wang Y, et al · · 2023 · cited 7× · PMID 37996817 · DOI 10.1186/s12916-023-03126-9

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Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other South China Center For Innovative Pharmaceuticals trials

Trials by the same sponsor.

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Data sources for this page

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