NCT05787028 (AD16) is a Phase 1 clinical trial of AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg in Alzheimer's Disease, sponsored by South China Center For Innovative Pharmaceuticals.

Who is sponsoring NCT05787028?

NCT05787028 is sponsored by South China Center For Innovative Pharmaceuticals.

What drugs are being tested in NCT05787028?

Interventions in NCT05787028: AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg, AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg.

What condition does NCT05787028 study?

NCT05787028 studies Alzheimer's Disease.

Is NCT05787028 still recruiting?

NCT05787028 is currently completed. Last updated 1 December 2023.

Last reviewed 2023-12-01 · How we verify

NCT05787028: AD16

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 1 December 2023

What this trial tests

Phase 1 trial testing AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg in Alzheimer's Disease in 70 participants. Completed in 31 May 2020.

Timeline

30 January 2019

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	South China Center For Innovative Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	30 January 2019
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across China

Drugs / interventions tested

AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg — full drug profile →
AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg

Conditions studied

Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

South China Center For Innovative Pharmaceuticals — full company profile →

Who can join

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Alzheimer's Disease

Currently open trials in the same condition.

NCT07457138 — Lombard Cohort of Brain Health Services · recruiting
NCT07234942 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants Wit · Phase 1 · recruiting
NCT07479914 — Art of Memory for Cognitive Enhancement in the Monza Brain Health Service · NA · active not recruiting
NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease · Phase 1 · recruiting
NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease · Phase 2 · recruiting

Other South China Center For Innovative Pharmaceuticals trials

Trials by the same sponsor.

NCT05806177 — Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects · Phase 1 · completed
NCT05787041 — The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05787028 (US National Library of Medicine, public domain)
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/NCT05787028.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing