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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04745104




Registration number
NCT04745104
Ethics application status
Date submitted
1/12/2020
Date registered
9/02/2021

Titles & IDs
Public title
A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
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
Secondary ID [1] 0 0
SHR-1707-I-101-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf
Timepoint [2] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax
Timepoint [3] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax
Timepoint [4] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F
Timepoint [5] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F
Timepoint [6] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2
Timepoint [7] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [8] 0 0
Pharmacokinetics MRT
Timepoint [8] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [9] 0 0
Pharmacodynamics
Timepoint [9] 0 0
Start of Treatment to end of study (approximately 12 weeks)
Secondary outcome [10] 0 0
Anti-Drug antibody
Timepoint [10] 0 0
Start of Treatment to end of study (approximately 12 weeks)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2022
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Atridia Pty Limited - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04745104