A Phase 1, randomised, 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

Occurring Dates
to
Participant Duration
5 Days / 4 Nights (in house stay) + 5 Follow up visits
State of study
South Australia
Overview

In this study, we are looking to evaluate the safety and tolerability of SHR-1707 when given as an intravenous (IV) infusion in healthy young adult and elderly volunteers. The study will also involve collection of pharmacokinetic (PK), pharmacodynamic (PD) and anti-drug antibodies (ADA) blood samples of SHR-1707 to measure how much SHR-1707 is in the bloodstream after dosing and what effect it has on the body.

Shanghai Hengrui Pharmaceutical Co, Ltd have developed SHR-1707 as a potential treatment for Alzheimer’s disease. SHR-1707 is a humanized anti-amyloid β (Aβ) monoclonal antibody – this is a type of antibody made in a laboratory which combines a human antibody with a small part of monoclonal antibody from a mouse or rat. The mouse or rat part of the antibody binds to the target antigen (any substance that causes your immune system to produce antibodies), whilst the human part makes our body’s immune system less likely to destroy it. It works by blocking formation of Aβ plaques or activating microglia (immune cells in the brain) to engulf various forms of Aβ in the brain which in turn protects the brain cells (neurons) and reduces the cognitive decline seen in Alzheimer’s patients. SHR-1707 has not been given to humans before.

This study will involve up to 62 male and female volunteers in 2 parts and is only being conducted at CMAX Clinical Research Pty Ltd.

You should be aware that the test medication used in this study is experimental and has not yet been approved by the TGA (Therapeutic Goods Administration) in Australia, or any other Regulatory Agency responsible for approving medicines for human use.

Further information

The study is being conducted at CMAX Clinical Research in Adelaide, South Australia. If you'd like to learn more, let us know via e-mail to [email protected], research team will be in touch.

This study has been approved by the Bellberry Human Research Ethics Committee (reference number: HREC2020-10-1084).

Study Address
Level 5, 18a North Terrace Adelaide
South Australia 5000
Full Name
Victoria Ingleson
Institute
CMAX Clinical Research
Phone Number
0413 063 547