NCT01020708已完成1 期
A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon
研究概览
简要总结
This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9 patients will be enrolled in this study, allowing for up to 3 replacement or additional patients.
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)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years
- •They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild active disease or disease in remission.
- •Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI with a sigmoidoscopy score of 1 point or less and Physician's rating of disease score of 1 point or less (mild or remission).
- •Laboratory data:
- •White blood cell count between 4,500 and 10,000 cells/mL
- •Platelet count: 150,000-450,000 cells/mL
- •Hemoglobin > 10.0 g/dL
- •Total bilirubin < 1.5 mg/dL
- •Aspartate aminotransferase < 100 u/dL
- •Alanine aminotransferase < 100 u/dL
- •Alkaline phosphatase < 250 u/dL
- •Blood urine nitrogen < 40 mg/dL
- •Creatinine < 1.5 mg/dL
- •Amylase < 150 U/L
- •Satisfied one of the following:
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.
- •Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.
- •They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
排除标准
- •Subjects will be excluded if:
- •They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
- •They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- •They receive a Physician's rating of disease severity as part of the modified UCDAI of 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
- •They have shown evidence of high grade dysplasia on endoscopic examinations.
- •Their stool contains enteric pathogens or Clostridium difficile toxins.
- •They have a history of recurrent Clostridium difficile infection.
- •They have prior history of biologic therapy.
- •They have received systemic steroids or immunosuppressants within the previous 4 weeks.
- •Treatment in the last 2 weeks that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) and/or 5-ASA enema (e.g. Rowasa®).
- •They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
- •Positive pregnancy test or lactating subjects.
- •There is evidence of chemical abuse.
- •They have a known allergy to N-acetylcysteine or Mesalamine.
- •They have a history of failure to retain enemas.
- •Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
- •Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
研究组 & 干预措施
Comparator
Active Comparator
Mesalamine enema
干预措施: mesalamine (Drug)
结局指标
主要结局
To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon
时间窗: 6 weeks treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar LinesGlabellar Frown LinesNCT04996810Protox Inc.60
已完成
1 期
Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's DiseaseAlzheimer's DiseaseNCT02600130Longeveron Inc.33
招募中
1 期
A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy ParticipantsHealthy SubjectsNCT06727396Chong Kun Dang Pharmaceutical40
Unknown
2 期
Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisLeft-sided Ulcerative ColitisDistal Ulcerative ColitisUlcerative ColitisNCT01586533Altheus Therapeutics, Inc.120
已完成
1 期
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult SubjectsNon-diabetic Overweight or ObeseNCT06714955BrightGene Bio-Medical Technology Co., Ltd.30