A Trial of SHR2285 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT04829305
• Recruitment Status: Completed
• First Posted: April 2, 2021
• Last Update Posted: March 8, 2022
• Sponsor: Atridia Pty Ltd.
• Information provided by (Responsible Party): Atridia Pty Ltd.

Study Description

Brief Summary:

This is a phase 1 open-label study

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: SHR2285	Phase 1

Detailed Description:

This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR2285 in healthy subjects

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Three different cohorts can enroll healthy Caucasian participants; males and females in each cohort separately.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: May 20, 2021
• Actual Primary Completion Date: September 6, 2021
• Actual Study Completion Date: September 6, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low dose of SHR2285; The subjects will receive a single dose of SHR2285 (cohort 1).	Drug: SHR2285; SHR2285 is a selective inhibition of human FXIa small molecule compound.
Experimental: Medium dose of SHR2285; The subjects will receive a single dose of SHR2285 (cohort 2).	Drug: SHR2285; SHR2285 is a selective inhibition of human FXIa small molecule compound.
Experimental: High dose of SHR2285; The subjects will receive a single dose of SHR2285 (cohort 3).	Drug: SHR2285; SHR2285 is a selective inhibition of human FXIa small molecule compound.

Outcome Measures

Primary Outcome Measures :

1. Adverse events [ Time Frame: Start of Treatment to end of study (approximately 7 days) ]
   Incidence and severity of adverse events

Secondary Outcome Measures :

1. Pharmacokinetics-AUC0-last [ Time Frame: Start of Treatment to outpatient (approximately 3 days) ]
   Area under the concentration-time curve from time 0 to last time point after SHR2285 administration
2. Pharmacokinetics-AUC0-inf [ Time Frame: Start of Treatment to outpatient (approximately 3 days) ]
   Area under the concentration-time curve from time 0 to infinity after SHR2285 administration
3. Pharmacokinetics-Tmax [ Time Frame: Up to 3 days ]
   Time to Cmax of SHR2285 and its metabolite SHR164471
4. Pharmacokinetics-Cmax [ Time Frame: Up to 3 days ]
   Maximum observed concentration of SHR2285 and its metabolite SHR164471
5. Pharmacokinetics-CL/F [ Time Frame: Up to 3 days ]
   Apparent clearance of SHR2285 and its metabolite SHR164471
6. Pharmacokinetics-Vz/F [ Time Frame: Up to 3 days ]
   Apparent volume of distribution during terminal phase of SHR2285 and its metabolite SHR164471
7. Pharmacokinetics-t1/2 [ Time Frame: Up to 3 days ]
   Terminal elimination half-life of SHR2285 and its metabolite SHR164471
8. Coagulation factor XI (FXI) activity [ Time Frame: Up to 3 days ]
   Coagulation factor XI (FXI) activity
9. Percentage change of coagulation factor XI (FXI) activity thromboplastin time (APTT) and fold change from baseline [ Time Frame: Up to 3 days ]
   Percentage change of coagulation factor XI (FXI) activity
10. Activated partial thromboplastin time [ Time Frame: Up to 3 days ]
    Activated partial thromboplastin time
11. Fold change of activated partial thromboplastin time from baseline [ Time Frame: Up to 3 days ]
    Fold change of activated partial thromboplastin time from baseline
12. Prothrombin time [ Time Frame: Up to 3 days ]
    Prothrombin time
13. Fold change of prothrombin time from baseline [ Time Frame: Up to 3 days ]
    Fold change of prothrombin time from baseline
14. International normalized ratio [ Time Frame: Up to 3 days ]
    International normalized ratio
15. Fold change of international normalized ratio from baseline [ Time Frame: Up to 3 days ]
    Fold change of international normalized ratio from baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

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).

Contacts and Locations

Locations

Australia, Western Australia

Linear Clinical research

Perth, Western Australia, Australia, 6009

Sponsors and Collaborators

Atridia Pty Ltd.

Investigators

• Principal Investigator: Dr Jasmine Daisy Williams; Study Principal Investigator

More Information

• Responsible Party: Atridia Pty Ltd.
• ClinicalTrials.gov Identifier: NCT04829305
• Other Study ID Numbers: SHR2285-105
• First Posted: April 2, 2021
• Last Update Posted: March 8, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No