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Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients. - Trial NCT05681819

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.

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NCT05681819
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05681819
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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

Study Focus

Alzheimer's Disease

SHR-1707

Interventional

drug

Sponsor & Location

Shanghai Hengrui Pharmaceutical Co., Ltd.

Timeline & Enrollment

Phase 1

Feb 20, 2023

Aug 18, 2025

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 disease
Alzheimer disease, unspecified
Other Alzheimer disease
Dementia in Alzheimer disease
Dementia in Alzheimer disease, unspecified

Data Source

ClinicalTrials.gov

NCT05681819

Non-Device Trial