Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects and Psoriasis Subjects

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.7 sites in 1 country9 target enrollmentJune 19, 2024

ConditionsGeneralized Pustular Psoriasis

InterventionsTQH2929 Injection

DrugsTQH2929 Injection

Overview

Phase: Phase 1
Intervention: TQH2929 Injection
Conditions: Generalized Pustular Psoriasis
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Enrollment: 9
Locations: 7
Primary Endpoint: Adverse events (AE)
Status: Active, not recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.

Registry

clinicaltrials.gov

Start Date

June 19, 2024

End Date

December 1, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults aged between 18 and 75 years (inclusive)，both male and female；
•A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017；
•Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
•Body mass index (BMI) within 18\~36 kg/m2；
•Major organ function is good;
•Patients must be able to understand and sign a written informed consent document;
•Patients must be able to complete study-related procedures and questionnaires;
•Female and male subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Female subjects need to serum pregnancy pregnancy test within 7 days before study enrollment.

Exclusion Criteria

•Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques；
•Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator；
•Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result;
•Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg)；
•History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening；
•Positive antibodies to treponema pallidum during screening；
•History of serious infection leading to hospitalization or intravenous infusion of antibiotics or antiviral therapy within 3 months prior to baseline;
•Active systemic infections requiring systemic antibiotics or systemic antiviral therapy within 4 weeks prior to baseline;
•History of opportunistic infection and parasitic infection within 6 months prior to the screening period；
•History of herpes zoster infection within 2 months prior to baseline；

Arms & Interventions

TQH2929 Injection (900 mg)

TQH2929 Injection is administered as a single dose.

Intervention: TQH2929 Injection

Outcomes

Primary Outcomes

Adverse events (AE)

Time Frame: From the first dose to 113 days after the last dose

The occurrence of all adverse events (AE).

Serious adverse events (SAE)

Time Frame: From the first dose to 113 days after the last dose

The occurrence of all serious adverse events (SAE).

Treatment-related adverse events(TRAE)

Time Frame: From the first dose to 113 days after the last dose

The occurrence of all treatment-related adverse events(TRAE).

Clinical laboratory abnormalities

Time Frame: From the first dose to 113 days after the last dose

Incidence of participants with clinical laboratory abnormalities

Secondary Outcomes

Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Apparent clearance (CL/F)(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Anti-drug antibodies (ADA)(Single dose: within 1 hour (pre-dose), Days 15, 57, 85, and 113 post-dose)
Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) pustulation subscore of 0/1 at Weeks 1,2,4(1, 2 and 4 weeks post-dose)
Time to reach maximum observed serum concentration (Tmax)(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Maximum serum concentration (Cmax)(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Apparent volume of distribution (Vd/F)(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Half-life (t1/2)(Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose)
Percent change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at weeks 1,2,4(Baseline and 1,2,4 weeks post-dose)
Change from baseline in dermatology life quality index (DLQI) score at weeks 1,2,4(Baseline and 1,2,4 weeks post-dose.)
Change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at week 1,2,4.(Baseline and 1,2,4 weeks post-dose)
Proportion of patients with psoriasis symptom scale (PSS) score of 0 at week 1,2,4.(1,2,4 weeks post-dose)
Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) score of 0 or 1 at week 1(Baseline and 1,2,4 weeks post-dose)
Change from baseline in psoriasis symptom scale (PSS) score at week 1,2,4(Baseline and 1,2,4 weeks post-dose)