Healthy Volunteers
Conditions
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 SHR8735 in healthy subjects
Interventions
DRUGSHR8735
SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
Sponsors
Atridia Pty Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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). * Severe, active psychiatric conditions that require ongoing treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Start of Treatment to end of study (approximately 28 days) | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics-AUC0-last | Start of Treatment to end of study (approximately 15 days) | Area under the concentration-time curve from time 0 to last time point after SHR8735 administration |
| Pharmacokinetics-AUC0-inf | Start of Treatment to end of study (approximately 15 days) | Area under the concentration-time curve from time 0 to infinity after SHR8735 administration |
| Pharmacokinetics-Tmax | Up to 15 days | Time to Cmax of SHR8735 |
| Pharmacokinetics-Cmax | Up to 15 days | Maximum observed concentration of SHR8735 |
| Pharmacokinetics-CL/F | Up to 15 days | Apparent clearance of SHR8735 |
| Pharmacokinetics-Vz/F | Up to 15 days | Apparent volume of distribution during terminal phase of SHR8735 |
| Pharmacokinetics-t1/2 | Up to 15 days | Terminal elimination half-life of SHR8735 |
| Change from baseline to end of treatment for platelet count | Up to 28 days | — |
Countries
Australia
Outcome results
None listed