BioequivalencePhase 1NCT04527484
A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
A Phase 1 study testing SHR-1314 in people with Bioequivalence, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- SHR-1314
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2020to 30 Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
- Men or women at least 18 years and no more than 45 years of age at time of screening.
- Men with a body weight ≥50 kg or women with a body weight ≥45kg, with BMI range from 18 to 25.
- Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.
Who cannot join
- Presence of significant medical problems, with investigator's judge that not proper to participate clinical study
- History of hypersensitivity to any of study drug constituent
- History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
- History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
- Those who have participated in any clinical study for any drug or medical device within 3 months before screening
Show all 10Show fewer
- Those who have been vaccinated with live attenuated vaccine within 12 weeks prior to screening
- History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Subjects judged by the investigator as unsuitable for participating in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-center, Randomized, Parallel, Open-label , Bioequivalence Study to Compare the Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1
- Conditions
- Bioequivalence
- Being tested
- SHR-1314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
each group subjects will be given different formulations of SHR-1314
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | SHR-1314 Vial Receives: Drug: SHR-1314 |
| Group B | Active comparator | SHR-1314 PFS Receives: Drug: SHR-1314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration
Compare the AUC0-last of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
Cmax: Observed maximum serum concentration
Compare the Cmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
AUC0-∞: Area under the serum concentration-time curve from time zero to infinity
Compare the AUC0-∞ of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
Secondary outcomes (6)
Tmax : Time at which observed maximum concentration occurs
Compare the Tmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
CL/F: Apparent clearance
Compare the CL/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
t1/2: Terminal half-life
Compare the t1/2 of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
V/F:Apparent volume of distribution
Compare the V/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
Incidence and severity of adverse events (AEs).
Compare Incidence and severity of AE at 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Measured: from Day1 to Day113
Anti-drug Antibodies (ADAs)
Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.
Measured: from Day1 to Day113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start20 Aug 2020 (estimated)
- Primary completion10 Jan 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527484
- Sponsor's protocol ID
- SHR-1314-105
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Parallel, Open-label , Bioequivalence Study to Compare the Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04527484
- Acronym / sponsor ID
- SHR-1314-105
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2020 (estimated)
- Primary completion
- 10 Jan 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 26 Aug 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 study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: SHR-1314SHR-1314 Vial |
| Group B | Active comparator | Drug: SHR-1314SHR-1314 PFS |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained before any assessment is performed.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
- Men or women at least 18 years and no more than 45 years of age at time of screening.
- Men with a body weight ≥50 kg or women with a body weight ≥45kg, with BMI range from 18 to 25.
- Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.
Key exclusion criteria (10 listed)
- Presence of significant medical problems, with investigator's judge that not proper to participate clinical study
- History of hypersensitivity to any of study drug constituent
- History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
- History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
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-1314each group subjects will be given different formulations of SHR-1314 | Drug | Group A, Group B |
Primary outcome
AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration
Time frame: from Day1 to Day113
Compare the AUC0-last of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Cmax: Observed maximum serum concentration
Time frame: from Day1 to Day113
Compare the Cmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
AUC0-∞: Area under the serum concentration-time curve from time zero to infinity
Time frame: from Day1 to Day113
Compare the AUC0-∞ of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
6 secondary outcomes
Tmax : Time at which observed maximum concentration occurs
Time frame: from Day1 to Day113
CL/F: Apparent clearance
Time frame: from Day1 to Day113
t1/2: Terminal half-life
Time frame: from Day1 to Day113
V/F:Apparent volume of distribution
Time frame: from Day1 to Day113
Incidence and severity of adverse events (AEs).
Time frame: from Day1 to Day113
Anti-drug Antibodies (ADAs)
Time frame: from Day1 to Day113
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1314 in people with Bioequivalence, run by Jiangsu HengRui Medicine Co., Ltd..
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 10 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: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Xu, Ph.D (0186 021-68868370, PRS_admin@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration (time frame: from Day1 to Day113). The study lists 3 primary outcomes in all. 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 26 Aug 2020.