NCT06114745CompletedPhase 1
A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 11 Oct 2023
- Start date
- 17 Apr 2024
- Primary completion date
- 8 Jul 2025
- Lead sponsor
- Atridia Pty Ltd.
- Diseases
- Alzheimer disease
- NCT number
- NCT06114745
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 2
- From 17 Apr 2024 to the primary completion date, 8 Jul 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment due to other medical or neurological factors (non-AD).
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
Lab values
- Inability to tolerate MRI examination or have contraindications to MRI examination.
- 6\. Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.
- 7\. Exclusion criteria related to general or laboratory tests, as listed in the protocol.
- 8\. The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.
- 9\. Severe visual or hearing impairment, unable to cooperate in the scale examination.
- 10\. Patients suspected to be allergic to Aβ antibody drugs and their excipients.
- 11\. Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.
- 12\. History of drug abuse and/or drug addiction within 1 year prior to screening.
- 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.
- 15\. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.
- 16\. Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.
- 17\. Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
Who the study is looking for
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
- Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
- Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive)at screening or baseline.
- The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
- The subjects should have a stable caregiver who will help the patients to participate in the whole study process.
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Southern Neurology Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.