A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The Percentage of Participants With Adverse Events
研究概览
简要总结
The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
- •Plaque psoriasis for at least 6 months prior to study enrollment
排除标准
- •Clinically significant psoriasis flare
- •Unstable doses of pain relief medication
- •Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
- •Treatment with any biologic therapy
- •Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
- •Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers
- •Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event
- •Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI
- •Currently smoking ≥ 10 cigarettes per day or equivalent
- •Active tuberculosis or other infection
- •Current or previous malignancies
- •Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
研究组 & 干预措施
PG102 0.3 mg/kg
Lowest dose PG102
干预措施: PG102 (Drug)
PG102 1 mg/kg
Second dose PG102
干预措施: PG102 (Drug)
Placebo (phosphate-buffered saline)
Control
干预措施: Placebo comparator (Drug)
结局指标
主要结局
The Percentage of Participants With Adverse Events
时间窗: Three months
The Number of Reported Adverse Events
时间窗: Three months
This was an exploratory study and all safety endpoints were considered.
The Number of Episodes of Change in Vital Signs
时间窗: Three months
Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 \& 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.
The Number of Episodes of Change in Electrocardiogram
时间窗: Three months
Episodes of clinically significant change in 12-lead electrocardiogram predose,1 \& 4 hours and 1 \& 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.
The Number of Episodes of Change From Screening in Laboratory Assessments
时间窗: Three months
Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.
次要结局
未报告次要终点