Healthy VolunteersPhase 1NCT04701216
A Trial of SHR8735 in Healthy Subjects
A Phase 1 study testing SHR8735 in people with Healthy Volunteers, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a phase 1 open-label study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SHR8735
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Feb 2021to 15 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects
This is a phase 1 open-label study.
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- SHR8735
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8735Drug
SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SHR8735 cohort 1 | Experimental | The subjects will receive a multiple dose of SHR8735 (low dose). Receives: Drug: SHR8735 |
| Experimental: SHR8735 cohort 2 | Experimental | The subjects will receive a single dose of SHR8735 (medium dose). Receives: Drug: SHR8735 |
| Experimental: SHR8735 cohort 3 | Experimental | The subjects will receive a single dose of SHR8735 (high dose). Receives: Drug: SHR8735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of adverse events
Measured: Start of Treatment to end of study (approximately 28 days)
Secondary outcomes (8)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR8735 administration
Measured: Start of Treatment to end of study (approximately 15 days)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR8735 administration
Measured: Start of Treatment to end of study (approximately 15 days)
Pharmacokinetics-Tmax
Time to Cmax of SHR8735
Measured: Up to 15 days
Pharmacokinetics-Cmax
Maximum observed concentration of SHR8735
Measured: Up to 15 days
Pharmacokinetics-CL/F
Apparent clearance of SHR8735
Measured: Up to 15 days
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR8735
Measured: Up to 15 days
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR8735
Measured: Up to 15 days
Change from baseline to end of treatment for platelet count
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start11 Feb 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Sun, Dr, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701216
- Sponsor's protocol ID
- SHR8735-I-113
- Status last verified
- Nov 2021
- First submitted
- 6 Jan 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT04701216
- Acronym / sponsor ID
- SHR8735-I-113
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: SHR8735 cohort 1 | Experimental | Drug: SHR8735The subjects will receive a multiple dose of SHR8735 (low dose). |
| Experimental: SHR8735 cohort 2 | Experimental | Drug: SHR8735The subjects will receive a single dose of SHR8735 (medium dose). |
| Experimental: SHR8735 cohort 3 | Experimental | Drug: SHR8735The subjects will receive a single dose of SHR8735 (high dose). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR8735SHR8735 is an thrombopoietin receptor agonist to promote platelet production. | Drug | Experimental: SHR8735 cohort 1, Experimental: SHR8735 cohort 2, Experimental: SHR8735 cohort 3 |
Primary outcome
Adverse events
Time frame: Start of Treatment to end of study (approximately 28 days)
Incidence and severity of adverse events
8 secondary outcomes
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 15 days)
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 15 days)
Pharmacokinetics-Tmax
Time frame: Up to 15 days
Pharmacokinetics-Cmax
Time frame: Up to 15 days
Pharmacokinetics-CL/F
Time frame: Up to 15 days
Pharmacokinetics-Vz/F
Time frame: Up to 15 days
Pharmacokinetics-t1/2
Time frame: Up to 15 days
Change from baseline to end of treatment for platelet count
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Sun, Dr principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR8735 in people with Healthy Volunteers, run by Atridia Pty Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Start of Treatment to end of study (approximately 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.