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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04745104
Registration number
NCT04745104
Ethics application status
Date submitted
1/12/2020
Date registered
9/02/2021
Date last updated
12/07/2022
Titles & IDs
Public title
A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
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Scientific 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
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Secondary ID [1]
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SHR-1707-I-101-AUS
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SHR-1707
Treatment: Drugs - Placebo
Experimental: SHR-1707 Dose level 1 - SHR-1707 or placebo is administered intravenous to young healthy subjects
Experimental: SHR-1707 Dose level 2 - SHR-1707 or placebo is administered intravenous to young healthy subjects
Experimental: SHR-1707 Dose level 3 - SHR-1707 or placebo is administered intravenous to young healthy subjects
Experimental: SHR-1707 Dose level 4 - SHR-1707 or placebo is administered intravenous to young healthy subjects
Experimental: SHR-1707 Dose level 5 - SHR-1707 or placebo is administered intravenous to young healthy subjects
Experimental: SHR-1707 Dose level 3 (Elderly subjects) - SHR-1707 or placebo is administered intravenous to Elderly subjects
Treatment: Drugs: SHR-1707
SHR-1707 will be administered through IV infusion
Treatment: Drugs: Placebo
Placebo will be administered through IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse events
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Assessment method [1]
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Incidence and severity of adverse events
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Timepoint [1]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [1]
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Pharmacokinetics-AUC0-last
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Assessment method [1]
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Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration
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Timepoint [1]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [2]
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Pharmacokinetics-AUC0-inf
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Assessment method [2]
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Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration
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Timepoint [2]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [3]
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Pharmacokinetics-Tmax
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Assessment method [3]
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Time to Cmax of SHR-1707
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Timepoint [3]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [4]
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Pharmacokinetics-Cmax
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Assessment method [4]
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Maximum observed concentration of SHR-1707
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Timepoint [4]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [5]
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Pharmacokinetics-CL/F
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Assessment method [5]
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Apparent clearance of SHR-1707
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Timepoint [5]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [6]
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Pharmacokinetics-Vz/F
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Assessment method [6]
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Apparent volume of distribution during terminal phase of SHR-1707
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Timepoint [6]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [7]
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Pharmacokinetics-t1/2
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Assessment method [7]
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Terminal elimination half-life of SHR-1707
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Timepoint [7]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [8]
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Pharmacokinetics MRT
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Assessment method [8]
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Mean residence time of SHR-1707
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Timepoint [8]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [9]
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Pharmacodynamics
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Assessment method [9]
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Change from baseline of plasma biomarker concentrations
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Timepoint [9]
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Start of Treatment to end of study (approximately 12 weeks)
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Secondary outcome [10]
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Anti-Drug antibody
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Assessment method [10]
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The percentage of subjects with positive ADA titers over time for SHR-1707.
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Timepoint [10]
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Start of Treatment to end of study (approximately 12 weeks)
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Eligibility
Key inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily
participate in the trial,
2. 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
3. Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32
kg/m2 (inclusive) at screening and baseline
4. 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
5. WOCBP agree to take effective contraceptive methods
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Severe injuries or surgeries within 6 months before screening
2. ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at
screening or baseline visits
3. QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening
and baseline
4. Known history or suspected of being allergic to the study drug.
5. 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
6. Live (attenuated) vaccination within 1 month before screening
7. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood
transfusion within 3 months before screening.
8. History of alcohol abuse in the past 12 months of screening
9. History of illicit or prescription drug abuse or addiction within 12 months of
screening
10. More than 5 cigarettes daily for 12 months before screening
11. Participation in clinical trials of other investigational drugs (include placebo) or
medical devices within 3 months prior to screening
12. Researchers and relevant staff of the research center or other persons directly
involved in the implementation of the program
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/03/2022
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Atridia Pty Limited - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Atridia Pty Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04745104
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04745104
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