Alzheimer's DiseasePhase 1NCT04973189
A Study of SHR-1707 in Healthy Young Adult and Elderly Subjects
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
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- 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
- 63 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2021to 13 Jan 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
- Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2
- Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~28 kg/m2 (inclusive)
- Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects
- WOCBP agree to take effective contraceptive methods
Who cannot join
- Severe injuries or surgeries within 6 months before screening
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at screening
- ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
- QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
- Known history or suspected of being allergic to Aβ antibody
- Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose [The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use]), or within 5 half-lives
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- Live (attenuated) vaccination within 1 month before screening
- Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
- History of alcohol abuse in the past 12 months of screening
- History of illicit or prescription drug abuse or addiction within 12 months of screening
- More than 5 cigarettes daily for 12 months before screening
- Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
- Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program
- The instigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
The second Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Phase 1, Randomized, 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
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.
- Conditions
- Alzheimer's Disease
- Being tested
- 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
A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults.
PlaceboDrug
A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.
SHR-1707Drug
A single dose of SHR-1707 by intravenous (IV) infusion in elderly subjects.
PlaceboDrug
A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects.
| Study group | Role | What they receive |
|---|---|---|
| A single dose of SHR-1707 by intravenous infusion in healthy young adults. | Experimental | Not described Receives: Drug: SHR-1707 |
| placebo in healthy young adults. | Placebo comparator | Not described Receives: Drug: Placebo |
| A single dose of SHR-1707 by intravenous infusion in elderly subjects. | Experimental | Not described Receives: Drug: SHR-1707 |
| placebo in elderly subject | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Incidence and severity of adverse events
Measured: Start of Treatment to end of study (approximately 12 weeks)
Secondary outcomes (10)
Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration
Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration
Measured: Start of Treatment to end of study (approximately 12 weeks)
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration
Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration
Measured: Start of Treatment to end of study (approximately 12 weeks)
Time to Cmax (Tmax) of SHR-1707
Time to Cmax of SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
Maximum observed concentration (Cmax) of SHR-1707
Maximum observed concentration of SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
Terminal elimination half-life (t1/2) of SHR-1707
Terminal elimination half-life of SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
Clearance (CL) of SHR-1707
Clearance of SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
Volume of distribution (Vss) of SHR-1707
Volume of distribution of SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
Mean residence time (MRT) of SHR-1707
Mean residence time of SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
The change from baseline in plasma Aβ40 and Aβ42 concentrations
The change from baseline in plasma Aβ40 and Aβ42 concentrations will be measured to determine the degree of change over time.
Measured: Start of Treatment to end of study (approximately 12 weeks)
Number of subjects with Anti-SHR-1707 antibodies
Number of subjects with positive ADA titers over time for SHR-1707
Measured: Start of Treatment to end of study (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start8 May 2021
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1707 compared with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 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
- NCT04973189
- Sponsor's protocol ID
- SHR-1707-101
- Status last verified
- May 2023
- First submitted
- 8 Jun 2021
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang Y, Qiu H, Fan Y, Zhang Q, Qin H, Wu J, Zhang X, Liu Y, Zhou R, Zhang Q, Ye Z, Ma J, Xu Y, Feng S, Fei Y, Li N, Cui X, Dong F, Wang Q, Shen K, Shakib S, Williams J, Hu W. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies. Alzheimers Res Ther. 2024 Oct 10;16(1):218. doi: 10.1186/s13195-024-01584-8.
PubMed 39390616
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, 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
- ClinicalTrials.gov ID
- NCT04973189
- Acronym / sponsor ID
- SHR-1707-101
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 22 Jul 2021 (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.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- SHR-1707 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| A single dose of SHR-1707 by intravenous infusion in healthy young adults. | Experimental | Drug: SHR-1707 |
| placebo in healthy young adults. | Placebo comparator | Drug: Placebo |
| A single dose of SHR-1707 by intravenous infusion in elderly subjects. | Experimental | Drug: SHR-1707 |
| placebo in elderly subject | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
- Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2
- Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~28 kg/m2 (inclusive)
- Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects
- WOCBP agree to take effective contraceptive methods
Key exclusion criteria (14 listed)
- Severe injuries or surgeries within 6 months before screening
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at screening
- ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
- QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
- Known history or suspected of being allergic to Aβ antibody
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-1707A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults. | Drug | A single dose of SHR-1707 by intravenous infusion in healthy young adults. |
| PlaceboA single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults. | Drug | placebo in healthy young adults. |
| SHR-1707A single dose of SHR-1707 by intravenous (IV) infusion in elderly subjects. | Drug | A single dose of SHR-1707 by intravenous infusion in elderly subjects. |
| PlaceboA single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects. | Drug | placebo in elderly subject |
Primary outcome
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Incidence and severity of adverse events
10 secondary outcomes
Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Time to Cmax (Tmax) of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Maximum observed concentration (Cmax) of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Terminal elimination half-life (t1/2) of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Clearance (CL) of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Volume of distribution (Vss) of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Mean residence time (MRT) of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
The change from baseline in plasma Aβ40 and Aβ42 concentrations
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Number of subjects with Anti-SHR-1707 antibodies
Time frame: Start of Treatment to end of study (approximately 12 weeks)
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 18 May 2023.
- Derived from this study: PubMed 39390616Yang Y, Qiu H, Fan Y, Zhang Q, Qin H, Wu J, Zhang X, Liu Y, Zhou R, Zhang Q, Ye Z, Ma J, Xu Y, Feng S, Fei Y, Li N, Cui X, Dong F, Wang Q, Shen K, Shakib S, Williams J, Hu W. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies. Alzheimers Res Ther. 2024 Oct 10;16(1):218. doi: 10.1186/s13195-024-01584-8.
- Individual participant dataSharing planned: Undecided
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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 5 inclusion and 14 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 18 May 2023. 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?
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability (time frame: Start of Treatment to end of study (approximately 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973189, which also lists 1 linked publication.
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 18 May 2023.