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NCT05806177: MAD
Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects
Phase 1 trial testing AD16 30mg、40mg in Alzheimer Disease in 20 participants. Completed in 31 July 2020.
31 July 2020
Quick facts
| Lead sponsor | South China Center For Innovative Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 26 May 2020 |
| Primary completion | 31 July 2020 |
| Estimated completion | 31 July 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- AD16 30mg、40mg — full drug profile →
- AD16 Placebo 30mg、40mg
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05806177
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other South China Center For Innovative Pharmaceuticals trials
Trials by the same sponsor.
- NCT05787041 — The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects · Phase 1 · completed
- NCT05787028 — Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05806177 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by South China Center For Innovative Pharmaceuticals
- Last refreshed: 1 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05806177.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing