A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis
Overview
- Phase
- Phase 1
- Intervention
- SHR-1314
- Conditions
- Axial Spondyloarthritis
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
Detailed Description
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
- •Have a history of back pain ≥3 months with age at onset \<45 years.
- •Have active axSpA defined as BASDAI ≥4 at screening and baseline.
- •Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
- •In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
- •If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
Exclusion Criteria
- •History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
- •Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
- •Total ankylosis of the spine.
- •Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
- •Have either a current diagnosis or a recent history of malignant disease.
- •Are pregnant or breastfeeding.
Arms & Interventions
Cohort 1
Multiple subcutaneous injections of SHR-1314 dose 1
Intervention: SHR-1314
Cohort 2
Multiple subcutaneous injections of SHR-1314 dose 2
Intervention: SHR-1314
Cohort 3
Multiple subcutaneous injections of SHR-1314 dose 3
Intervention: SHR-1314
Cohort 4
Multiple subcutaneous injections of SHR-1314 dose 4
Intervention: SHR-1314
Cohort 5
Multiple subcutaneous injections of SHR-1314 dose 5
Intervention: SHR-1314
Outcomes
Primary Outcomes
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
Time Frame: Baseline to 169 days after dose administration
Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events. 1. Incidence of Treatment-Emergent Adverse Events 2. Incidence of Injection site reaction
Secondary Outcomes
- Time to elimination half-life (t1/2) of SHR-1314(Baseline to 169 days after dose administration)
- Proportion of Participants Achieving an ASAS20 Response(Week2, 4, 6, 8, 12,16)
- Time to maximum observed serum concentration (tmax) of SHR-1314(Baseline to 169 days after dose administration)
- Maximum observed serum concentration (Cmax) of SHR-1314(Baseline to 169 days after dose administration)
- Assessment of development of Anti-drug Antibodies (ADAs)(Baseline to 169 days after dose administration)