NCT05681819

Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients.

A Phase Ib, Randomized, Double-blind, Placebo-controlled, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Alzheimer's Disease
Drug/Device/Intervention
SHR-1707
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Timeline & enrollment
Phase
Phase 1
Start date
Feb 20, 2023
End date
Aug 18, 2025
Enrollment
41 participants
Primary outcome

To assess the number of patients with adverse events (AEs),To assess the number of patients with clinically significant change from baseline in vital signs values,,To assess the number of patients with clinically significant change in physical examination,,To assess the number of patients with clinically significant change from baseline in laboratory examination,,To assess the number of patients with clinically significant change from baseline in 12-ECG values,,To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)

Summary

Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of
 SHR-1707 In Patients with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild
 Alzheimer's Disease.

ICD-10 classifications
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05681819
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05681819 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Alzheimer's Disease. Target enrollment is 41 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.