A Trial of SHR2285 in Healthy Subjects

• Sponsor: Atridia Pty Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04829305
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 8.7

Study Details

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
• 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.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: Sep 6, 2021
• Actual Study Completion Date: Sep 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 [Start of Treatment to end of study (approximately 7 days)]

   Incidence and severity of adverse events

Secondary Outcome Measures

1. Pharmacokinetics-AUC0-last [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 [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 [Up to 3 days]

   Time to Cmax of SHR2285 and its metabolite SHR164471

4. Pharmacokinetics-Cmax [Up to 3 days]

   Maximum observed concentration of SHR2285 and its metabolite SHR164471

5. Pharmacokinetics-CL/F [Up to 3 days]

   Apparent clearance of SHR2285 and its metabolite SHR164471

6. Pharmacokinetics-Vz/F [Up to 3 days]

   Apparent volume of distribution during terminal phase of SHR2285 and its metabolite SHR164471

7. Pharmacokinetics-t1/2 [Up to 3 days]

   Terminal elimination half-life of SHR2285 and its metabolite SHR164471

8. Coagulation factor XI (FXI) activity [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 [Up to 3 days]

   Percentage change of coagulation factor XI (FXI) activity

10. Activated partial thromboplastin time [Up to 3 days]

    Activated partial thromboplastin time

11. Fold change of activated partial thromboplastin time from baseline [Up to 3 days]

    Fold change of activated partial thromboplastin time from baseline

12. Prothrombin time [Up to 3 days]

    Prothrombin time

13. Fold change of prothrombin time from baseline [Up to 3 days]

    Fold change of prothrombin time from baseline

14. International normalized ratio [Up to 3 days]

    International normalized ratio

15. Fold change of international normalized ratio from baseline [Up to 3 days]

    Fold change of international normalized ratio from baseline

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Linear Clinical research	Perth	Western Australia	Australia	6009

Sponsors and Collaborators

• Atridia Pty Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Atridia Pty Ltd.
• ClinicalTrials.gov Identifier: NCT04829305
• Other Study ID Numbers: SHR2285-105
• First Posted: Apr 2, 2021
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

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

Study Results

No Results Posted as of Mar 8, 2022