AsthmaPhase 1NCT04855591
A Trial of SHR-1703 in Healthy Subjects
A Phase 1 study testing SHR-1703 in people with Asthma, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- SHR-1703
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Jun 2021to 18 Nov 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
- Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
- Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
- 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 30-days after last scheduled follow-up visit.
Who cannot join
- Known history or suspected of being allergic to the study drug.
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
- Use of any medicine within 4-weeks prior to the IP administration
- Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
- Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
Show all 11Show fewer
- Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
- Patients with known or suspected parasitic infection within 6 months before screening
- Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)
- More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
- History of alcohol abuse within 3 months prior to the IP administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.
Read the detailed description
The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
- Conditions
- Asthma
- Being tested
- SHR-1703, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1703Drug
SHR-1703 will be administered subcutaneously
PlaceboDrug
Placebo of SHR-1703 will be administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| SHR-1703 Dose Level 1 | Experimental | Dose level 1 SHR-1703 Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703 Dose Level 2 | Experimental | Dose level 2 SHR-1703 Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703 Dose Level 3 | Experimental | Dose level 3 SHR-1703 Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703 Dose Level 4 (optional) | Experimental | Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review Receives: Drug: SHR-1703; 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 34 weeks)
Secondary outcomes (9)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR-1703 administration
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-1703 administration
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-Tmax
Time to Cmax of SHR-1703
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-1703
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-CL/F
Apparent clearance of SHR-1703
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR-1703
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-1703
Measured: Start of Treatment to end of study (approximately 34 weeks)
Pharmacodynamics-Eosinophils
Absolute eosinophils account and change from baseline in percentage
Measured: Start of Treatment to end of study (approximately 34 weeks)
Anti-drug-antibody
The percentage of subjects with positive ADA titers over time for SHR-1703
Measured: Start of Treatment to week 22 after IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start14 Jun 2021
- Primary completion13 Sep 2021
- Study completion18 Nov 2021
Why it stopped: Adjustment of the clinical development plan for this product globally
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Richard Friend, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855591
- Sponsor's protocol ID
- SHR-1703-104-AUS
- Status last verified
- Nov 2021
- First submitted
- 20 Apr 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects
- ClinicalTrials.gov ID
- NCT04855591
- Acronym / sponsor ID
- SHR-1703-104-AUS
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of the clinical development plan for this product globally
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 22 Apr 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 randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.
Detailed description
The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR-1703 Dose Level 1 | Experimental | Drug: SHR-1703, Drug: PlaceboDose level 1 SHR-1703 |
| SHR-1703 Dose Level 2 | Experimental | Drug: SHR-1703, Drug: PlaceboDose level 2 SHR-1703 |
| SHR-1703 Dose Level 3 | Experimental | Drug: SHR-1703, Drug: PlaceboDose level 3 SHR-1703 |
| SHR-1703 Dose Level 4 (optional) | Experimental | Drug: SHR-1703, Drug: PlaceboDose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
- Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
- 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 30-days after last scheduled follow-up visit.
Key exclusion criteria (11 listed)
- Known history or suspected of being allergic to the study drug.
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
- Use of any medicine within 4-weeks prior to the IP administration
- Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
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-1703SHR-1703 will be administered subcutaneously | Drug | SHR-1703 Dose Level 1, SHR-1703 Dose Level 2, SHR-1703 Dose Level 3, SHR-1703 Dose Level 4 (optional) |
| PlaceboPlacebo of SHR-1703 will be administered subcutaneously | Drug | SHR-1703 Dose Level 1, SHR-1703 Dose Level 2, SHR-1703 Dose Level 3, SHR-1703 Dose Level 4 (optional) |
Primary outcome
Adverse events
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Incidence and severity of adverse events
9 secondary outcomes
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-Tmax
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-Cmax
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-CL/F
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-Vz/F
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacokinetics-t1/2
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Pharmacodynamics-Eosinophils
Time frame: Start of Treatment to end of study (approximately 34 weeks)
Anti-drug-antibody
Time frame: Start of Treatment to week 22 after IP administration
Results and safety
The study was stopped early (reason given: Adjustment of the clinical development plan for this product globally). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Dr Richard Friend principal investigator
Nucleus Network
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-1703 in people with Asthma, 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 1 Dec 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 was stopped early (reason given: Adjustment of the clinical development plan for this product globally). Results are not available in the source record.
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 34 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 1 Dec 2021.