Alzheimer's DiseasePhase 1NCT05681819
A Study of SHR-1707 With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
A Phase 1 study testing SHR-1707 in people with Alzheimer's Disease, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety, tolerability and pharmacodynamics of intravenous administration of SHR-1707 In patients with mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SHR-1707
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2023to 13 Aug 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
- Age ≥ 55 and ≤ 85 on the date of signing the informed consent, males or females;
- BMI ≥ 19 kg/m2 and ≤ 32 kg/m2, weight ≥ 45 kg and ≤ 100 kg at screening or baseline;
- Must meet the diagnostic criteria for MCI due to AD or mild AD;
- The total score of HAMD-17 should be ≤ 10 scores at screening and baseline;
- The score of Hachinski ischemic scale should be ≤ 4 scores at screening and baseline;
- Qualitative amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD;
- Agreed to test ApoE genotype;
- Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 3 months prior to the baseline visit.
Who cannot join
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment;
- Cannot tolerate MRI or has contraindications to MRI, has significant lesions shown on MRI during screening, or has other conditions that the investigator believes may bring a significant risk to the subject;
- Suspected allergy to Aβ antibody drugs and excipients;
- Patients who had severe trauma or had undergone surgery within 6 months prior to screening, or were scheduled to undergo surgery during the trial;
Show all 26Show fewer
- History of moderate (3b) or severe renal failure or insufficiency;
- Uncontrolled hypertension: systolic blood pressure > 160 mmHg and diastolic blood pressure >100 mmHg in supine position during screening or baseline;
- 12-lead ECG showed QTcF > 450ms for male and > 470ms for female during screening;
- History of hypoglycemic coma or uncontrolled diabetes 6 months prior to the screening period;
- Thyroid dysfunction;
- Had unstable or clinically significant cardiovascular disease within 1 year prior to the screening period, had or currently has atrial fibrillation;
- History of malignancy within 5 years prior to screening;
- Patients with clinically significant systemic immunosuppression due to the persistent effects of immunosuppressive drugs;
- Human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody and hepatitis C virus antibody (HCV-Ab) were positive during screening. Hepatitis B active subjects (Hepatitis B virus surface antigen (HBsAg) positive with HBV DNA > upper limit of normal);
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times ULN, or total bilirubin exceeding 2 times ULN;
- Folic acid or vitamin B12 below the lower limit of normal;
- coagulation disorders;
- According to the investigators, the subjects were suicidal or had committed suicidal behavior in the six months before the screening period;
- Severe visual or hearing impairment, unable to cooperate with the completion of the scale;
- A woman who is pregnant, or a woman of childbearing potential whose pregnancy test results are positive, or who is breastfeeding; or has a plan to have a child, unwilling or unable to take effective contraceptive measures within 30 days prior to the screening period or six months after the last use of the investigational drug;
- History of drug abuse or addiction;
- Three months prior to the randomization period or planned to use dual antiplatelet or anticoagulant drugs during the trial;
- Received any passive immunotherapy or other long-acting biologics used to prevent or delay cognitive decline within 1 year prior to screening;
- Investigators and relevant staff of the research Centre or others directly involved in programme implementation;
- The investigator considers that there are any circumstances that would cause the subject to be unable to complete the study or pose a significant risk to the subject or other factors that would interfere with the subject's ability to complete the study evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Randomized, Double-blind, Placebo-controlled, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
This study aims to evaluate the safety, tolerability and pharmacodynamics of intravenous administration of SHR-1707 In patients with mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- SHR-1707, SHR-1707 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-1707Drug
Multiple-ascending Dose
SHR-1707 placeboDrug
Multiple-ascending Dose
| Study group | Role | What they receive |
|---|---|---|
| SHR-1707 | Experimental | Up to4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 injection Receives: Drug: SHR-1707 |
| SHR-1707 placebo | Placebo comparator | Up to 4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 placebo injection Receives: Drug: SHR-1707 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the number of patients with adverse events (AEs)
Measured: Week 26
To assess the number of patients with clinically significant change from baseline in vital signs values
Measured: Week 26
To assess the number of patients with clinically significant change in physical examination
Measured: Week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Measured: Week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Measured: Week 26
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
Measured: Week 26
Secondary outcomes (8)
To assess the change from baseline in Brain Amyloid Plaque Deposition as measured by Aβ PET
Measured: Week26/52/78
To assess the ADA
Measured: Week 26
To assess the number of patients with adverse events (AEs)
Measured: Week 52/78
To assess the number of patients with clinically significant change from baseline in vital signs values
Measured: Week 52/78
To assess the number of patients with clinically significant change in physical examination
Measured: Week 52/78
To assess the number of patients with clinically significant change from baseline in laboratory examination
Measured: Week 52/78
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Measured: Week 52/78
To assess the number of patients with clinically significant change in Head brain MRI (cerebral edema, microbleeding, etc.)
Measured: Week 52/78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start17 Feb 2023
- Primary completion18 May 2024
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681819
- Sponsor's protocol ID
- SHR-1707-102
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2023
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double-blind, Placebo-controlled, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05681819
- Acronym / sponsor ID
- SHR-1707-102
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 12 Jan 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.
This study aims to evaluate the safety, tolerability and pharmacodynamics of intravenous administration of SHR-1707 In patients with mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.
Study design
- Primary purpose
- Other
- 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 |
|---|---|---|
| SHR-1707 | Experimental | Drug: SHR-1707Up to4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 injection |
| SHR-1707 placebo | Placebo comparator | Drug: SHR-1707 placeboUp to 4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 placebo injection |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 55 and ≤ 85 on the date of signing the informed consent, males or females;
- BMI ≥ 19 kg/m2 and ≤ 32 kg/m2, weight ≥ 45 kg and ≤ 100 kg at screening or baseline;
- Must meet the diagnostic criteria for MCI due to AD or mild AD;
- The total score of HAMD-17 should be ≤ 10 scores at screening and baseline;
- The score of Hachinski ischemic scale should be ≤ 4 scores at screening and baseline;
Key exclusion criteria (26 listed)
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment;
- Cannot tolerate MRI or has contraindications to MRI, has significant lesions shown on MRI during screening, or has other conditions that the investigator believes may bring a significant risk to the subject;
- Suspected allergy to Aβ antibody drugs and excipients;
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-1707Multiple-ascending Dose | Drug | SHR-1707 |
| SHR-1707 placeboMultiple-ascending Dose | Drug | SHR-1707 placebo |
Primary outcome
To assess the number of patients with adverse events (AEs)
Time frame: Week 26
To assess the number of patients with clinically significant change from baseline in vital signs values
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
8 secondary outcomes
To assess the change from baseline in Brain Amyloid Plaque Deposition as measured by Aβ PET
Time frame: Week26/52/78
To assess the ADA
Time frame: Week 26
To assess the number of patients with adverse events (AEs)
Time frame: Week 52/78
To assess the number of patients with clinically significant change from baseline in vital signs values
Time frame: Week 52/78
To assess the number of patients with clinically significant change in physical examination
Time frame: Week 52/78
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: Week 52/78
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time frame: Week 52/78
To assess the number of patients with clinically significant change in Head brain MRI (cerebral edema, microbleeding, etc.)
Time frame: Week 52/78
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 5 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
1 site 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 in people with Alzheimer's Disease, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
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 8 inclusion and 26 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
To assess the number of patients with 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 5 May 2026.