PsoriasisPhase 1NCT02934412
A Study of SHR-1314 in Healthy Subjects
A Phase 1 study testing SHR-1314 in people with Psoriasis, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) 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
- Psoriasis
- What is being tested?
- SHR-1314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Aug 2016to 30 Jun 2017
- 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
- Provide written informed consent before any study assessment is performed.
- Male or female between the ages of 18 and 55 years (inclusive) at screening,
- Good general health as defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including measurement of vital signs, 12-lead ECG, and clinical laboratory tests. (Evaluations must be considered "not clinically significant (NCS)" if outside of the reference range).
- Body Mass Index (BMI) of 18 to 30 kg/m2 (inclusive), and a total body weight ≥50 kg at screening.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
Who cannot join
- Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
- Use of other investigational drugs within 5 half-lives of screening, or within 30 days of screening (for small molecules), or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- 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 human chorionic gonadotropin laboratory test at screening or Day -1.
- Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until 2 months after drug administration (approximately 5 half-lives). Effective contraception is defined use of two of the following methods of contraception:
- Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps).
- Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
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- Male sterilization
- Use of established oral, injected or implanted hormonal methods of contraception,
- Use of an intrauterine device or intrauterine system.
- Blood donation of approximately 500 mL within 56 days prior to dosing on Day 1 and for the duration of the study.
- A positive urine drug screen at screening and Day -1.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 100 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening.
- Use of tobacco or nicotine containing products (including e-cigarettes) at any time within six months before screening and for the duration of the study.
- History of hypersensitivity to any of the study biologics, drugs or to drugs of similar chemical classes.
- History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- History or complication of tuberculosis.
- Has a clinically significant abnormality on the screening chest x-ray that, in the opinion of the investigator, could affect the subject's safety or ability to participate in the study; including, but not limited to, evidence of previous exposure to tuberculosis.
- History of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result at screening.
- Positive hepatitis B or hepatitis C test result at Screening
- Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic pulmonary disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- Use of live vaccines (attenuated) within 3 months before study Day 1 or at any time during the study.
- Evidence of latent tuberculosis by QuantiFERON screening.
- Use of any of the following, unless agreed as non-clinically relevant by the Investigator and the Sponsor:
- Prescription medication within four weeks prior to dosing on Day 1
- Over-the-counter medication (excluding paracetamol) within seven days prior to the treatment day. Paracetamol use must be limited to 2 g per day and no more than three days usage in the four weeks prior to dosing on Day 1
- Vitamin therapy or dietary supplements within seven days prior to dosing on Day 1 and for the duration of the study
- Herbal supplements within 28 days prior to the dosing on Day 1 and for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety and Pharmacokinetics of SHR-1314 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of approximately 40 subjects dosed at one study site.
Read the detailed description
This study will consist of a 27-day screening period (Days -28 to -2), clinic check-in (Day -1), a treatment day (Day 1), a 10-week treatment period and a study completion evaluation (Day 71) as shown in above figure.
A review of blinded interim PK data will be conducted by the Safety Review Committee (SRC) to confirm the study sampling schedule captures the full PK profile of SHR-1314. This interim analysis will be conducted for Cohort 1 and may be conducted for subsequent cohorts if serum SHR-1314 concentrations in Cohort 1 or any of the subsequent cohorts are below the limit of quantification of the assay preventing evaluation of the PK profile.
The expected duration of participation for each subject will be up to 99 days. Subjects who are withdrawn for reasons other than safety may be replaced at the discretion of the sponsor.
- Conditions
- Psoriasis
- Being tested
- SHR-1314, placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
placeboDrug
Single subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1314 20mg | Experimental | 20mg SHR-1314 or placebo is administered subcutaneously to healthy subjects Receives: Drug: SHR-1314; Drug: placebo |
| SHR-1314 40mg | Experimental | 40mg SHR-1314 or placebo is administered subcutaneously to healthy subjects Receives: Drug: SHR-1314; Drug: placebo |
| SHR-1314 80mg | Experimental | 80mg SHR-1314 or placebo is administered subcutaneously to healthy subjects Receives: Drug: SHR-1314; Drug: placebo |
| SHR-1314 160mg | Experimental | 160mg SHR-1314 or placebo is administered subcutaneously to healthy subjects Receives: Drug: SHR-1314; Drug: placebo |
| SHR-1314 240mg | Experimental | 240mg SHR-1314 or placebo is administered subcutaneously to healthy subjects Receives: Drug: SHR-1314; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: 70 days
Secondary outcomes (2)
Serum concentrations of SHR01314
Measured: 70 days
Serum anti-drug antibodies
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start22 Aug 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Farinola, B.Sc,BMBS, Principal investigator, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934412
- Sponsor's protocol ID
- SHR-1314-A101
- Status last verified
- Nov 2017
- First submitted
- 20 Sep 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety and Pharmacokinetics of SHR-1314 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02934412
- Acronym / sponsor ID
- SHR-1314-A101
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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 escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of approximately 40 subjects dosed at one study site.
Detailed description
This study will consist of a 27-day screening period (Days -28 to -2), clinic check-in (Day -1), a treatment day (Day 1), a 10-week treatment period and a study completion evaluation (Day 71) as shown in above figure.
A review of blinded interim PK data will be conducted by the Safety Review Committee (SRC) to confirm the study sampling schedule captures the full PK profile of SHR-1314. This interim analysis will be conducted for Cohort 1 and may be conducted for subsequent cohorts if serum SHR-1314 concentrations in Cohort 1 or any of the subsequent cohorts are below the limit of quantification of the assay preventing evaluation of the PK profile.
The expected duration of participation for each subject will be up to 99 days. Subjects who are withdrawn for reasons other than safety may be replaced at the discretion of the sponsor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SHR-1314 20mg | Experimental | Drug: SHR-1314, Drug: placebo20mg SHR-1314 or placebo is administered subcutaneously to healthy subjects |
| SHR-1314 40mg | Experimental | Drug: SHR-1314, Drug: placebo40mg SHR-1314 or placebo is administered subcutaneously to healthy subjects |
| SHR-1314 80mg | Experimental | Drug: SHR-1314, Drug: placebo80mg SHR-1314 or placebo is administered subcutaneously to healthy subjects |
| SHR-1314 160mg | Experimental | Drug: SHR-1314, Drug: placebo160mg SHR-1314 or placebo is administered subcutaneously to healthy subjects |
| SHR-1314 240mg | Experimental | Drug: SHR-1314, Drug: placebo240mg SHR-1314 or placebo is administered subcutaneously to healthy subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provide written informed consent before any study assessment is performed.
- Male or female between the ages of 18 and 55 years (inclusive) at screening,
- Good general health as defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including measurement of vital signs, 12-lead ECG, and clinical laboratory tests. (Evaluations must be considered "not clinically significant (NCS)" if outside of the reference range).
- Body Mass Index (BMI) of 18 to 30 kg/m2 (inclusive), and a total body weight ≥50 kg at screening.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
Key exclusion criteria (27 listed)
- Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
- Use of other investigational drugs within 5 half-lives of screening, or within 30 days of screening (for small molecules), or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- 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 human chorionic gonadotropin laboratory test at screening or Day -1.
- Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until 2 months after drug administration (approximately 5 half-lives). Effective contraception is defined use of two of the following methods of contraception:
- Blood donation of approximately 500 mL within 56 days prior to dosing on Day 1 and for the duration of the study.
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-1314Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. | Drug | SHR-1314 160mg, SHR-1314 20mg, SHR-1314 240mg, SHR-1314 40mg, SHR-1314 80mg |
| placeboSingle subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. | Drug | SHR-1314 160mg, SHR-1314 20mg, SHR-1314 240mg, SHR-1314 40mg, SHR-1314 80mg |
Primary outcome
Incidence and severity of adverse events
Time frame: 70 days
2 secondary outcomes
Serum concentrations of SHR01314
Time frame: 70 days
Serum anti-drug antibodies
Time frame: 70 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 14 Nov 2017.
- 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.
Nicholas Farinola, B.Sc,BMBS principal investigator
Royal Adelaide Hospital
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-1314 in people with Psoriasis, 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 27 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 14 Nov 2017. 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?
Incidence and severity of adverse events (time frame: 70 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 14 Nov 2017.