Alzheimer's Disease (AD)Phase 1NCT06114745
A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
A Phase 1 study testing SHR-1707 injection in people with Alzheimer's Disease (AD), run by Atridia Pty Ltd. at 3 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- SHR-1707 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 3 sitesAustralia
- Study dates
- 17 Apr 2024to 8 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Austin Health
Melbourne, Victoria
Liverpool Hospital
Sydney, New South Wales
Southern Neurology
Sydney, New South Wales
About this study
Official title: 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
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.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- SHR-1707 injection, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1707 injectionDrug
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
PlaceboDrug
Placebo will be administered through IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 SHR-1707 | Experimental | SHR-1707 is administered intravenously. Receives: Drug: SHR-1707 injection |
| Dose level 1 Placebo | Placebo comparator | Placebo is administered intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events(AEs)
To assess the number of patients with adverse events
Measured: week 26
Baseline in vital signs value
To assess the number of patients with clinically significant change from baseline in vital signs value
Measured: week 26
Physical examination
To assess the number of patients with clinically significant change in physical examination
Measured: week 26
Laboratory examination
To assess the number of patients with clinically significant change from baseline in laboratory examination
Measured: week 26
Baseline in 12-ECG values
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Measured: week 26
MRI
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
Measured: week 26
Secondary outcomes (3)
Aβ positron emission tomography (PET)
To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET)
Measured: week 26
Concentrations of SHR-1707
To assess concentrations of SHR-1707 after multiple doses of administration
Measured: week 26
Anti-Drug antibody
To assess the incidence and time of occurrence of anti-SHR-1707 antibodies
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start17 Apr 2024
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1707 injection compared with placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114745
- Sponsor's protocol ID
- SHR-1707-103
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06114745
- Acronym / sponsor ID
- SHR-1707-103
- Conditions
- Alzheimer's Disease (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- SHR-1707 injection compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 SHR-1707 | Experimental | Drug: SHR-1707 injectionSHR-1707 is administered intravenously. |
| Dose level 1 Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered intravenously. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1707 injectionDrug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion | Drug | Dose level 1 SHR-1707 |
| PlaceboPlacebo will be administered through IV infusion | Drug | Dose level 1 Placebo |
Primary outcome
Adverse events(AEs)
Time frame: week 26
To assess the number of patients with adverse events
Baseline in vital signs value
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in vital signs value
Physical examination
Time frame: week 26
To assess the number of patients with clinically significant change in physical examination
Laboratory examination
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Baseline in 12-ECG values
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
MRI
Time frame: week 26
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
3 secondary outcomes
Aβ positron emission tomography (PET)
Time frame: week 26
Concentrations of SHR-1707
Time frame: week 26
Anti-Drug antibody
Time frame: week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Alzheimer's Disease (AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1707 injection in people with Alzheimer's Disease (AD), run by Atridia Pty Ltd. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events(AEs) (time frame: week 26). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.