NCT06373094Not yet recruiting

A Single Dose Escalation Study of HHT201 in Healthy Subjects

Name: Clinical Trial NCT06373094
Creator: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Keywords: Alzheimer Disease, Donepezil Dihydroxynaphthalate for Injection, Phase 1, drug, clinical trial, China

A Single-center, Open-label, Single-dose Ascending Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of HHT201 (Donepezil Dihydroxynaphthalate for Injection) in Healthy Subjects

Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Phase 1ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Alzheimer Disease
Drug/Device/Intervention: Donepezil Dihydroxynaphthalate for Injection
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Funder: Zhejiang Huahai Pharmaceutical Co., Ltd.
Location: Taizhou, China

Timeline & enrollment

Phase: Phase 1
Start date: Jun 01, 2024
End date: Mar 31, 2025
Enrollment: 64 participants

Primary outcome

Adverse events,Number of Participants With Abnormal Laboratory Values,Number of Participants With Abnormal ECG QT Interval,Number of Participants With Abnormal Vital signs,Number of Participants With Abnormal Physical examination,VAS

Summary

The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.

ICD-10 classifications

Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06373094
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06373094 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Synergy Pharmaceutical Sciences Co., Ltd. and is currently Not yet recruiting. The study focuses on Alzheimer Disease. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.