Clinical trial NCT04829305: A Trial of SHR2285 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Three different cohorts can enroll healthy Caucasian participants; males and females in each cohort separately.
Primary purpose: TREATMENT

Brief summary: This is a phase 1 open-label study

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

Eligibility 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).

Primary outcomes:
measure: Adverse events
timeFrame: Start of Treatment to end of study (approximately 7 days)
Secondary outcomes:
measure: Pharmacokinetics-AUC0-last
timeFrame: Start of Treatment to outpatient (approximately 3 days)
measure: Pharmacokinetics-AUC0-inf
timeFrame: Start of Treatment to outpatient (approximately 3 days)
measure: Pharmacokinetics-Tmax
timeFrame: Up to 3 days
measure: Pharmacokinetics-Cmax
timeFrame: Up to 3 days
measure: Pharmacokinetics-CL/F
timeFrame: Up to 3 days
measure: Pharmacokinetics-Vz/F
timeFrame: Up to 3 days
measure: Pharmacokinetics-t1/2
timeFrame: Up to 3 days
measure: Coagulation factor XI (FXI) activity
timeFrame: Up to 3 days
measure: Percentage change of coagulation factor XI (FXI) activity thromboplastin time (APTT) and fold change from baseline
timeFrame: Up to 3 days
measure: Activated partial thromboplastin time
timeFrame: Up to 3 days
measure: Fold change of activated partial thromboplastin time from baseline
timeFrame: Up to 3 days
measure: Prothrombin time
timeFrame: Up to 3 days
measure: Fold change of prothrombin time from baseline
timeFrame: Up to 3 days
measure: International normalized ratio
timeFrame: Up to 3 days
measure: Fold change of international normalized ratio from baseline
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical research
state: Western Australia
Study officials:
affiliation: Study Principal Investigator
name: Dr Jasmine Daisy Williams
role: PRINCIPAL_INVESTIGATOR
References: