The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout
详细描述
Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group.
Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Phase II is double-blind, participants and investigators are blind.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years ≤ age ≤65 years
- •Meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of acute arthritis of primary gout
- •Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
- •Body mass index of less than or equal to 45 kg/m2
- •Onset of current acute gout flare within 5 days prior to study entry
- •Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
- •History of gout flare prior to study entry
- •Exclusion criteria:
- •evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- •Presence of severe renal function impairment
- •Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry
- •Live vaccinations within 3 months prior to randomization
- •Requirement for administration of antibiotics against latent tuberculosis (TB)
- •Any active or recurrent bacterial, fungal, or viral infection
- •QTc>450ms for male, QTc>470ms for female
排除标准
- 未提供
研究组 & 干预措施
Genakumab for injection 195mg (Ib)
subcutaneous injection, single dose
干预措施: Genakumab for Injection (Drug)
Genakumab for injection 50mg (Ib)
subcutaneous injection, single dose
干预措施: Genakumab for Injection (Drug)
Genakumab for injection 100mg (Ib)
subcutaneous injection, single dose
干预措施: Genakumab for Injection (Drug)
Genakumab for injection 100mg (II)
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
干预措施: Genakumab for Injection (Drug)
Genakumab for injection 195mg (II)
Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose
干预措施: Genakumab for Injection (Drug)
Compound Betamethasone Injection 1ml (II)
Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose
干预措施: Placebo for Genakumab for Injection (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112
Blood samples will be collected at indicated time points for pharmacokinetic analysis.
pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS)
时间窗: 72 hours post-dose
0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain
次要结局
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(up to 16 weeks)
- High Sensitivity C-reactive Protein (hsCRP)(at 72 hours and 7 days, 4, 8 and 12 weeks post-dose)