NCT04745104

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707

Detailed description

The study will consist of two parts: Subjects will be randomized to receive SHR-1707 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	SHR-1707	SHR-1707 will be administered through IV infusion
DRUG	Placebo	Placebo will be administered through IV infusion

Timeline

• Start date: 2021-02-23
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2021-02-09
• Last updated: 2022-07-12

Locations

1 site across 1 country: Australia