SHR-1707 injection
DrugDrug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
NCT Number: NCT06114745
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.
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Notify Me55 year–85 year
All sexes
Interventional
Phase 1
Liverpool Hospital, Sydney, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.
14.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
Placebo will be administered through IV infusion
Time frame: week 26
To assess the number of patients with adverse events
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in vital signs value
Time frame: week 26
To assess the number of patients with clinically significant change in physical examination
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time frame: week 26
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
Time frame: week 26
To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET)
Time frame: week 26
To assess concentrations of SHR-1707 after multiple doses of administration
Time frame: week 26
To assess the incidence and time of occurrence of anti-SHR-1707 antibodies
Atridia Pty Ltd.
Industry
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of SHR-1707 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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