NL-OMON40621已完成不适用
A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects with Moderate to Severe Ulcerative Colitis - GS-US-326-0101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Have the ability to understand and sign a written informed consent
- •form, which must be obtained prior to initiation of study procedures
- •2. Males or non-pregnant, non-lactating females, ages 18 to 65 years,
- •3. Females of childbearing potential (see definition in Section 7.9) must
- •have a negative pregnancy test at Screening and Baseline.
- •4. All sexually active female subjects, of childbearing potential, must
- •agree to use a highly effective method of contraception during
- •heterosexual intercourse from Screening to study completion, and up
- •to 90 days post last dose of the study drug.
- •5. Male subjects who are sexually active are required to use barrier
- •contraception (condom with spermicide) during heterosexual
- •intercourse from Screening to study completion, and up to 90 days
- •post last dose of the study drug.
- •6. Documented diagnosis of UC with a minimum disease extent of
- •15 cm from the anal verge
- •7. Mayo Score:
- •* SAD cohort: Minimum modified Mayo Score of 3 (score > 3),
- •with a rectal bleeding and stool frequency sub-score of at least 1
- •* MAD cohort: Minimum Mayo Score of 6 (score > 6), with a
- •Mayo endoscopic sub-score of at least 2
- •8. Laboratory parameters:
- •* Hepatic panel (AST, ALT, total bilirubin, direct bilirubin,
- •alkaline phosphatase, LDH) * 2 times the ULN
- •* Serum creatinine * 1.5 times the ULN
- •* Hemoglobin * 10 g/dL (both males and females)
- •* Absolute neutrophil count (ANC) * 1.5 x 109/L (1,500 mm3)
- •* Platelets * 100 x 109/L
排除标准
- •1. Pregnant or lactating subjects
- •2. Known hypersensitivity to the study investigational medicinal
- •products, the metabolites or formulation excipients.
- •3. Exhibit severe UC as defined by the following criteria:
- •* *6 bloody stools daily AND one or more of the following:
- •* Oral temperature > 100.3°F ( or 38°C)
- •* Pulse > 90 beats/minute
- •* Hemoglobin < 10 g/dL (both males and females)
- •4. Current use of oral corticosteroids at a dose equivalent to
- •> 20 mg/day of prednisone
- •5. Any dose adjustment in oral corticosteroids or oral
- •immunosuppressants (6-MP, Azathioprine) , or oral 5-ASA
- •compounds within 30 days of Baseline
- •6. Use of rectal formulations of 5-ASA compounds or corticosteroids
- •within 2 weeks prior to randomization
- •7. Crohn*s disease or indeterminate colitis
- •8. History of colectomy, partial colectomy, or dysplasia on biopsy
- •9. Stool sample positive for Clostridium difficile (C. difficile) toxin, E.
- •coli, Salmonella, Shigella, Campylobacter or Yersinia
- •10. Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab,
- •Vedolizumab or Certolizumab within 8 weeks of randomization
- •11. Clinically significant active infection
- •12. Chronic medical or psychiatric problem that may interfere with
- •subject*s ability to comply with study procedures
- •13. Alcohol or drug abuse in the opinion of the Investigator
- •14. History of malignancy within the last 5 years except for patients who
- •have been treated for non-melanoma skin cancer or cervical
- •carcinoma in situ
- •15. Any other investigational therapy or investigational biologics use
- •within 8 weeks of randomization
- •16. Any chronic medical condition (including, but not limited to, cardiac
- •or pulmonary disease) that, in the opinion of the Investigator, would
- •make the subject unsuitable for the study or would prevent
- •compliance with the study protocol
研究者
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