NCT03768219终止1 期
Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending dose (MAD) study of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple doses of APVO210 in psoriasis patients and ulcerative colitis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Age 18 to 65 years old.
- •Body mass index (BMI) > 18.5 kg/m2 and < 30.0 kg/m2; minimum body weight of 50 kg.
- •Good health and no clinically significant findings on:
- •Physical examination
- •12-lead ECG
- •Clinical laboratory tests (serum chemistry, haematology, coagulation, urine drug screen, and urinalysis (UA))
- •Seated systolic blood pressure (BP) 90 to 140 mm Hg.
- •Seated diastolic BP 60 to 90 mm Hg.
- •Psoriasis Patients (Expansion Cohort):
- •Main Inclusion Criteria:
- •Clinical diagnosis of chronic plaque psoriasis with a disease duration of at least 6 months; patients with concurrent psoriatic arthritis may be enrolled.
- •Psoriasis Area and Severity Index (PASI) score ≥ 12 at baseline.
- •Psoriasis plaque BSA (Body surface area) ≥ 10%
- •PGA (Physician Global Assessment) ≥
- •Age 18 to 65 years old.
- •Body mass index > 18.5 and < 35.0 kg/m2; minimum body weight of 50 kg.
- •Ulcerative Colitis Patients (Expansion Cohort):
- •Main Inclusion Criteria:
- •Moderately to severely active ulcerative colitis as defined by:
- •Baseline Mayo Score of 6 to 12; and
- •Endoscopic sub-score ≥2 as read by central reader
- •Is intolerant, refractory, or only partially responsive to corticosteroids (not including budesonide), immunomodulators (azathioprine [AZA] or 6-mercaptopurine [6-MP], and methotrexate), or biologics.
- •Age 18 to 65 years old.
- •Body mass index > 18.5 and < 35.0 kg/m2; minimum body weight of 50 kg.
排除标准
- •Main Exclusion Criteria
- •Clinically significant manifestation of metabolic; hepatic; renal; haematological; pulmonary; cardiovascular; gastrointestinal; musculoskeletal; dermatological; urogenital; eye, ear, nose, and throat; psychiatric; or neurological disorders.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.2 times the upper limit of normal (ULN) as defined by the laboratory.
- •Positive hepatitis panel (hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV]) or positive human immunodeficiency virus (HIV) antibody.
- •Positive Quantiferon tuberculosis (TB) test at Screening Visit.
- •Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
- •Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
- •Psoriasis Patients (Expansion Cohort):
- •Main Exclusion Criteria:
- •History of malignancy, diagnosed or known to be active or actively treated within the past 5 years, other than resected lesions of low malignant potential, such as basal cell skin cancers or low risk squamous cell carcinomas of the skin.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) as defined by the laboratory.
- •Creatinine > 1.5 times ULN as defined by the laboratory.
- •Positive hepatitis panel (hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV]) or positive human immunodeficiency virus (HIV) antibody.
- •Positive Quantiferon tuberculosis (TB) test at Screening Visit.
- •Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
- •Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
- •Use of a prescription medication that could have an effect on psoriasis (eg, lithium, systemic steroids, immunosuppressants) during the 14 days before Check-in; use of prescription medications for psoriasis is not permitted until after the Follow-up Visit.
- •Non plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
- •Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB) phototherapy, use of tanning beds, or use of systemic medications such as methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Check-in.
- •Ulcerative Colitis Patients (Expansion Cohort):
- •Main Exclusion Criteria:
- •Ulcerative colitis requiring immediate surgical, endoscopic, or radiological intervention including massive haemorrhage, perforation and sepsis, suppurative complications, or toxic colon.
- •Stool positive for Clostridium difficile toxin, enteric pathogens, or ova and parasites.
- •Positive hepatitis panel (hepatitis B surface antigen [HBsAg] and anti hepatitis C virus [HCV]) or positive human immunodeficiency virus (HIV) antibody.
- •Positive Quantiferon tuberculosis (TB) test at Screening Visit.
- •Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
- •Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
- •Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB) phototherapy, use of tanning beds, or use of systemic medications such as methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Check-in.
结局指标
主要结局
Number of subjects with adverse events
时间窗: up to Day 57
Number of subjects with significant changes from baseline laboratory measurements
时间窗: up to Day 57
Number of subjects with clinical significant abnormalities found on physical examination
时间窗: up to Day 57
Number of ulcerative colitis patients with adverse events
时间窗: up to day 141
Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results
时间窗: up to day 141
Number of subjects with clinically relevant findings in vital signs
时间窗: up to Day 57
Number of psoriasis patients with adverse events
时间窗: up to day 141
Number of psoriasis patients with clinical significant abnormalities found on physical examination
时间窗: up to day 141
Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination
时间窗: up to day 141
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
时间窗: up to Day 57
Number of psoriasis patients with clinically relevant findings in vital signs
时间窗: up to day 141
Number of psoriasis patients with significant changes from baseline laboratory measurements
时间窗: up to day 141
Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results
时间窗: up to day 141
Number of ulcerative colitis patients with clinically relevant findings in vital signs
时间窗: up to day 141
Number of ulcerative colitis patients with significant changes from baseline laboratory measurements
时间窗: up to day 141
次要结局
- Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients(Up to day 141)
- Change in number of leukocytes by flow cytometry in psoriasis patients(Up to day 141)
- Change in number of leukocytes by flow cytometry in ulcerative colitis patients(Up to day 141)
- Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients(Up to day 141)
- Area under the plasma concentration versus time curve (AUC)(Up to day 57)
- The number of subjects who develop anti-drug antibodies to APVO210(Up to day 57)
- The number of psoriasis patients who develop anti-drug antibodies to APVO210(Up to day 141)
- The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210(Up to day 141)
- Serum level of Peak Plasma Concentration (Cmax)(Up to day 57)
- Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients(Up to day 141)
- Area under the plasma concentration versus time curve (AUC) for psoriasis patients(Up to day 141)
- Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.(Up to day 141)
- Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.(Up to day 141)
研究者
研究点 (2)
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