Healthy VolunteersPhase 1NCT04561128
A Trial of SHR-1819 in Healthy Subjects
A Phase 1 study testing SHR-1819 in people with Healthy Volunteers, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 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?
- SHR-1819
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2020to 7 Mar 2022
- 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
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
- Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
- Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.
Read the detailed description
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- SHR-1819, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1819Drug
SHR-1819 will be subcutaneously administered with different dose levels
PlaceboDrug
Placebo will be subcutaneously administered with different dose levels
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 | Experimental | Experimental: SHR-1819 Receives: Drug: SHR-1819 |
| Placebo | Placebo comparator | Placebo comparator: placebo Receives: Drug: Placebo |
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 13 weeks)
Secondary outcomes (10)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration
Measured: Start of Treatment to end of study (approximately 13 weeks)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration
Measured: Start of Treatment to end of study (approximately 13 weeks)
Pharmacokinetics-Tmax
Time to Cmax of SHR-1819
Measured: Up to 13 weeks
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-1819
Measured: Up to 13 weeks
Pharmacokinetics-CL/F
Apparent clearance of SHR-1819
Measured: Up to 13 weeks
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR-1819
Measured: Up to 13 weeks
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-1819
Measured: Up to 13 weeks
Change from baseline to end of treatment for TARC/CCL17
TARC/CCL17
Measured: Up to 13 weeks
Change from baseline to end of treatment for IgE
IgE
Measured: Up to 13 weeks
Immunogenicy of SHR-1819 after administration
Anti-drug antibody
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Nov 2020
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561128
- Sponsor's protocol ID
- SHR-1819-I-101-AUS
- Status last verified
- Jul 2022
- First submitted
- 29 Aug 2020
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04561128
- Acronym / sponsor ID
- SHR-1819-I-101-AUS
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 23 Sep 2020 (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 single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.
Detailed description
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 | Experimental | Drug: SHR-1819Experimental: SHR-1819 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparator: placebo |
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 (4 listed)
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
- Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
- Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
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 |
|---|---|---|
| SHR-1819SHR-1819 will be subcutaneously administered with different dose levels | Drug | SHR-1819 |
| PlaceboPlacebo will be subcutaneously administered with different dose levels | Drug | Placebo |
Primary outcome
Adverse events
Time frame: Start of Treatment to end of study (approximately 13 weeks)
Incidence and severity of adverse events
10 secondary outcomes
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 13 weeks)
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 13 weeks)
Pharmacokinetics-Tmax
Time frame: Up to 13 weeks
Pharmacokinetics-Cmax
Time frame: Up to 13 weeks
Pharmacokinetics-CL/F
Time frame: Up to 13 weeks
Pharmacokinetics-Vz/F
Time frame: Up to 13 weeks
Pharmacokinetics-t1/2
Time frame: Up to 13 weeks
Change from baseline to end of treatment for TARC/CCL17
Time frame: Up to 13 weeks
Change from baseline to end of treatment for IgE
Time frame: Up to 13 weeks
Immunogenicy of SHR-1819 after administration
Time frame: Up to 13 weeks
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 12 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR-1819 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 4 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 12 Jul 2022. 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. Some participants in this study may receive a placebo. 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 13 weeks)). 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 12 Jul 2022.