Trial Review

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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/NCT04829305




Registration number
NCT04829305
Ethics application status
Date submitted
30/03/2021
Date registered
2/04/2021
Date last updated
8/03/2022

Titles & IDs
Public title
A Trial of SHR2285 in Healthy Subjects
Scientific title
A Phase 1, Single Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Single Oral Administration in Healthy Caucasian Participants
Secondary ID [1] 0 0
SHR2285-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR2285

Experimental: Low dose of SHR2285 - The subjects will receive a single dose of SHR2285 (cohort 1).

Experimental: Medium dose of SHR2285 - The subjects will receive a single dose of SHR2285 (cohort 2).

Experimental: High dose of SHR2285 - The subjects will receive a single dose of SHR2285 (cohort 3).


Treatment: Drugs: SHR2285
SHR2285 is a selective inhibition of human FXIa small molecule compound.
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 7 days)
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last
Timepoint [1] 0 0
Start of Treatment to outpatient (approximately 3 days)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf
Timepoint [2] 0 0
Start of Treatment to outpatient (approximately 3 days)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax
Timepoint [3] 0 0
Up to 3 days
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax
Timepoint [4] 0 0
Up to 3 days
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F
Timepoint [5] 0 0
Up to 3 days
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F
Timepoint [6] 0 0
Up to 3 days
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2
Timepoint [7] 0 0
Up to 3 days
Secondary outcome [8] 0 0
Coagulation factor XI (FXI) activity
Timepoint [8] 0 0
Up to 3 days
Secondary outcome [9] 0 0
Percentage change of coagulation factor XI (FXI) activity thromboplastin time (APTT) and fold change from baseline
Timepoint [9] 0 0
Up to 3 days
Secondary outcome [10] 0 0
Activated partial thromboplastin time
Timepoint [10] 0 0
Up to 3 days
Secondary outcome [11] 0 0
Fold change of activated partial thromboplastin time from baseline
Timepoint [11] 0 0
Up to 3 days
Secondary outcome [12] 0 0
Prothrombin time
Timepoint [12] 0 0
Up to 3 days
Secondary outcome [13] 0 0
Fold change of prothrombin time from baseline
Timepoint [13] 0 0
Up to 3 days
Secondary outcome [14] 0 0
International normalized ratio
Timepoint [14] 0 0
Up to 3 days
Secondary outcome [15] 0 0
Fold change of international normalized ratio from baseline
Timepoint [15] 0 0
Up to 3 days

Eligibility
Key inclusion criteria
- Ability to understand the trial procedures and possible adverse events, volunteers to
participate in the trial, and provides written informed consent.

- Be able to comply with all the requirements and able to complete the study.

- Male or female aged between 18 years and 55 years (inclusive) at the date of signed
consent form.

- No clinically significant abnormalities in medical history, general physical
examination, vital signs, and laboratory tests.

- Men and women of childbearing potential (WOCBP) must agree to take effective
contraceptive methods and have no plan to have a child from signing the consent form
to 16 weeks after IP administration.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Receipt of any other investigational drugs or medical devices within 3 months prior to
screening (according to the date of signed consent form).

- History of illicit or prescription drug abuse or addiction within one year of
screening, or positive urine drug screen at screening and Day-1. The urine drug screen
may be repeated at the discretion of the investigator and the reason for repeat needs
to be documented clearly (e.g., suspicion of false positive due to diet).

- Receipt of any other investigational drugs or medical devices within 3 months prior to
screening (from the date of signed consent form).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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
20/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/09/2021
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical research - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

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
Dr Jasmine Daisy Williams
Address 0 0
Study Principal Investigator
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

No information has been provided regarding IPD availability


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/ct2/show/NCT04829305