AsthmaPhase 1NCT04800263
A Trial of SHR-1905 in Healthy Subjects
A Phase 1 study testing SHR-1905 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 and immunogenicity of subcutaneous administered SHR-1905 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-1905
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Jul 2021to 12 Nov 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.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
- For healthy subjects, no clinically significant abnormalities.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Who cannot join
- Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- Severe injuries or major surgeries within 6 months before screening.
- Subjects with infecious disease.
- Hyper/Hypotension at screening and at check in.
- Clinically significant abnormalities in 12-Lead ECG
- More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
Show all 13Show fewer
- Positive urine drug screen .
- Subject who cannot perform venous blood sampling.
- Known history or suspected of being allergic to the study drugs and their excipients.
- Use of any medicine within 4-weeks or within 5 half-lives
- History of alcohol abuse within 3 months prior to the IP administration .
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
- in the investigator's judgment, may increase the risk to the subject
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, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 in Healthy 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 and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.
Read the detailed description
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 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-1905, 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-1905Drug
SHR-1905 will be injected subcutaneously
PlaceboDrug
Placebo will be injected subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| SHR-1905 Dose Level 1 | Experimental | SHR-1905 Dose level 1 Receives: Drug: SHR-1905; Drug: Placebo |
| SHR-1905 Dose Level 2 | Experimental | SHR-1905 Dose level 2 Receives: Drug: SHR-1905; Drug: Placebo |
| SHR-1905 Dose Level 3 | Experimental | SHR-1905 Dose level 3 Receives: Drug: SHR-1905; Drug: Placebo |
| SHR-1905 Dose Level 4 | Experimental | SHR-1905 Dose level 4 Receives: Drug: SHR-1905; Drug: Placebo |
| SHR-1905 Dose Level 5 | Experimental | SHR-1905 Dose level 5 Receives: Drug: SHR-1905; 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 16 weeks)
Secondary outcomes (8)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration
Measured: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration
Measured: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Tmax
Time to Cmax of SHR-1905
Measured: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-1905
Measured: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-CL/F
Apparent clearance of SHR-1905
Measured: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR-1905
Measured: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-1905
Measured: Start of Treatment to end of study (approximately 16 weeks)
Anti-Drug antibody
The percentage of subjects with positive ADA titers over time for SHR-1905
Measured: Start of Treatment to end of study (approximately 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start27 Jul 2021
- Primary completion12 Nov 2022
- Study completion12 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 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
- NCT04800263
- Sponsor's protocol ID
- SHR-1905-I-101-AUS
- Status last verified
- May 2023
- First submitted
- 11 Mar 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fei Y, Li N, Qian W, Fan Y, Shen Y, Wang Q, McLendon K, Shen K. A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects. Front Pharmacol. 2024 Jul 15;15:1400696. doi: 10.3389/fphar.2024.1400696. eCollection 2024.
PubMed 39076593
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. 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, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04800263
- Acronym / sponsor ID
- SHR-1905-I-101-AUS
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 12 Nov 2022 (actual)
- First posted
- 16 Mar 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 and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.
Detailed description
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 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
- 5
| Arm | Type | Receives |
|---|---|---|
| SHR-1905 Dose Level 1 | Experimental | Drug: SHR-1905, Drug: PlaceboSHR-1905 Dose level 1 |
| SHR-1905 Dose Level 2 | Experimental | Drug: SHR-1905, Drug: PlaceboSHR-1905 Dose level 2 |
| SHR-1905 Dose Level 3 | Experimental | Drug: SHR-1905, Drug: PlaceboSHR-1905 Dose level 3 |
| SHR-1905 Dose Level 4 | Experimental | Drug: SHR-1905, Drug: PlaceboSHR-1905 Dose level 4 |
| SHR-1905 Dose Level 5 | Experimental | Drug: SHR-1905, Drug: PlaceboSHR-1905 Dose level 5 |
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.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
- For healthy subjects, no clinically significant abnormalities.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Key exclusion criteria (13 listed)
- Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- Severe injuries or major surgeries within 6 months before screening.
- Subjects with infecious disease.
- Hyper/Hypotension at screening and at check in.
- Clinically significant abnormalities in 12-Lead ECG
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-1905SHR-1905 will be injected subcutaneously | Drug | SHR-1905 Dose Level 1, SHR-1905 Dose Level 2, SHR-1905 Dose Level 3, SHR-1905 Dose Level 4, SHR-1905 Dose Level 5 |
| PlaceboPlacebo will be injected subcutaneously | Drug | SHR-1905 Dose Level 1, SHR-1905 Dose Level 2, SHR-1905 Dose Level 3, SHR-1905 Dose Level 4, SHR-1905 Dose Level 5 |
Primary outcome
Adverse events
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Incidence and severity of adverse events
8 secondary outcomes
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Tmax
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Cmax
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-CL/F
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Vz/F
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-t1/2
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Anti-Drug antibody
Time frame: Start of Treatment to end of study (approximately 16 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 10 May 2023.
- Derived from this study: PubMed 39076593Fei Y, Li N, Qian W, Fan Y, Shen Y, Wang Q, McLendon K, Shen K. A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects. Front Pharmacol. 2024 Jul 15;15:1400696. doi: 10.3389/fphar.2024.1400696. eCollection 2024.
- 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.
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-1905 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 5 inclusion and 13 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 10 May 2023. 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 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800263, which also lists 1 linked publication.
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 10 May 2023.