Safety, Tolerability and PK of SHR1314 in axSpA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03704428

Enrollment

Registered

2018-10-12

Start date

2018-04-19

Completion date

2020-01-14

Last updated

2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis

Keywords

SHR1314

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).

Interventions

DRUGSHR-1314

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria. 2. Have a history of back pain ≥3 months with age at onset \<45 years. 3. Have active axSpA defined as BASDAI ≥4 at screening and baseline. 4. Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP. 5. 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. 6. If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

Exclusion criteria

1. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection. 2. Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor. 3. Total ankylosis of the spine. 4. Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks. 5. Have either a current diagnosis or a recent history of malignant disease. 6. Are pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame	Description
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	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

Measure	Time frame	Description
Maximum observed serum concentration (Cmax) of SHR-1314	Baseline to 169 days after dose administration	maximum concentration (Cmax)
Time to maximum observed serum concentration (tmax) of SHR-1314	Baseline to 169 days after dose administration	Time to maximum concentration (Tmax)
Time to elimination half-life (t1/2) of SHR-1314	Baseline to 169 days after dose administration	t1/2
Assessment of development of Anti-drug Antibodies (ADAs)	Baseline to 169 days after dose administration	Incidence of development of Anti-drug Antibodies (ADAs)
Proportion of Participants Achieving an ASAS20 Response	Week2, 4, 6, 8, 12,16	ASAS20 Response

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026