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Alzheimer DiseasePhase 1NCT04745104

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

A Phase 1 study testing SHR-1707 in people with Alzheimer Disease, run by Atridia Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer 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
50 participants
Where
1 siteAustralia
Study dates
23 Feb 2021to 21 Mar 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • 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 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 19~32 kg/m2 (inclusive) at screening and baseline
  • 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
  • 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 the study drug.
  • 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
  • Live (attenuated) vaccination within 1 month before screening
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Atridia Pty Limited

    Sydney, New South Wales, 2000

Other trials in Australia

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

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707

Read the detailed description

The study will consist of two parts: Subjects will be randomized to receive SHR-1707 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

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

    SHR-1707 will be administered through IV infusion

  • PlaceboDrug

    Placebo will be administered through IV infusion

Study groups in NCT04745104
Study groupRoleWhat they receive
SHR-1707 Dose level 1ExperimentalSHR-1707 or placebo is administered intravenous to young healthy subjects
Receives: Drug: SHR-1707; Drug: Placebo
SHR-1707 Dose level 2ExperimentalSHR-1707 or placebo is administered intravenous to young healthy subjects
Receives: Drug: SHR-1707; Drug: Placebo
SHR-1707 Dose level 3ExperimentalSHR-1707 or placebo is administered intravenous to young healthy subjects
Receives: Drug: SHR-1707; Drug: Placebo
SHR-1707 Dose level 4ExperimentalSHR-1707 or placebo is administered intravenous to young healthy subjects
Receives: Drug: SHR-1707; Drug: Placebo
SHR-1707 Dose level 5ExperimentalSHR-1707 or placebo is administered intravenous to young healthy subjects
Receives: Drug: SHR-1707; Drug: Placebo
SHR-1707 Dose level 3 (Elderly subjects)ExperimentalSHR-1707 or placebo is administered intravenous to Elderly subjects
Receives: Drug: SHR-1707; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Incidence and severity of adverse events

    Measured: Start of Treatment to end of study (approximately 12 weeks)

Secondary outcomes (10)

  1. Pharmacokinetics-AUC0-last

    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)

  2. Pharmacokinetics-AUC0-inf

    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)

  3. Pharmacokinetics-Tmax

    Time to Cmax of SHR-1707

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  4. Pharmacokinetics-Cmax

    Maximum observed concentration of SHR-1707

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  5. Pharmacokinetics-CL/F

    Apparent clearance of SHR-1707

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  6. Pharmacokinetics-Vz/F

    Apparent volume of distribution during terminal phase of SHR-1707

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  7. Pharmacokinetics-t1/2

    Terminal elimination half-life of SHR-1707

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  8. Pharmacokinetics MRT

    Mean residence time of SHR-1707

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  9. Pharmacodynamics

    Change from baseline of plasma biomarker concentrations

    Measured: Start of Treatment to end of study (approximately 12 weeks)

  10. Anti-Drug antibody

    The percentage 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.

  1. First posted9 Feb 2021
  2. Study start23 Feb 2021
  3. Primary completion21 Mar 2022
  4. Study completion21 Mar 2022

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745104
Sponsor's protocol ID
SHR-1707-I-101-AUS
Status last verified
Jul 2022
First submitted
1 Dec 2020
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1707 in people with Alzheimer Disease, run by Atridia Pty Ltd. at 1 site 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 12 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 12 Jul 2022. 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 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. 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 (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 NCT04745104, 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 12 Jul 2022.

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