NCT06433531进行中（未招募）1 期
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 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2024年6月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 7
- 主要终点
- Adverse events (AE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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；
- •Subject has known or suspected autoimmune disease;
- •Receive major surgery within 4 weeks prior to the first dose;
- •Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
- •Subjects have history of significant drug allergies；
- •Use of the following medications within the prescribed time:
- •Receive topical drugs for the treatment of skin diseases within 1 weeks prior to baseline;
- •Receive systemic therapy within 4 weeks prior to baseline;
- •Receive regular phototherapy within 4 weeks prior to baseline;
- •Within 12 weeks prior to baseline, receive live (attenuated) vaccine;
- •Receive antibiotics and antivirals within 4 weeks prior to baseline.
- •People who are alcoholic, drug addicts, and known drug dependents;
- •Pregnant or Breasting feeding subject;
- •Received a blood transfusion within 4 weeks prior to the first dose;
- •Subject is unable to tolerate intravenous infusion administration;
- •During the period of participation in this study, participants had planned surgical procedures;
- •Have participated in clinical trials of other drugs or medical devices within 4 weeks prior to baseline;
- •In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
研究组 & 干预措施
TQH2929 Injection (900 mg)
Experimental
TQH2929 Injection is administered as a single dose.
干预措施: TQH2929 Injection (Drug)
结局指标
主要结局
Adverse events (AE)
时间窗: From the first dose to 113 days after the last dose
The occurrence of all adverse events (AE).
Serious adverse events (SAE)
时间窗: From the first dose to 113 days after the last dose
The occurrence of all serious adverse events (SAE).
Treatment-related adverse events(TRAE)
时间窗: From the first dose to 113 days after the last dose
The occurrence of all treatment-related adverse events(TRAE).
Clinical laboratory abnormalities
时间窗: From the first dose to 113 days after the last dose
Incidence of participants with clinical laboratory abnormalities
次要结局
- 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)
研究者
研究点 (7)
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