ACTRN12621000011886已完成1 期
A 2-part, randomised, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of FTP 637 in healthy volunteers.
Alumis Inc (formerly Esker Therapeutics, Inc)0 个研究点目标入组 87 人开始时间: 2021年1月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Body mass index greater than or equal to 18.0 and less than or equal to 32.0 kg/m2, with a body weight greater than or equal to 50 kg at screening.
- •- Be nonsmokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration and have a negative test for cotinine at the Screening visit and at check-in on Day -1.
- •- Medically healthy without clinically significant abnormalities at the screening visit, at check-in on Day -1 and pre-dose on Day 1
- •- Conventional 12-lead ECG recording in triplicate consistent with normal cardiac conduction and function
排除标准
- •- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically relevant.
- •- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
- •- Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- •- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- •- Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration.
- •- Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore, or branding that, in the opinion of the Investigator, would interfere with interpretation of skin adverse reaction assessments.
- •- Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase [GGT], bilirubin (total, conjugated and unconjugated) or alkaline phosphatase (ALP) or elevated 2.0-fold above ULN for aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Participants with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- •- Positive test results for active human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- •- History of active, latent or inadequately treated tuberculosis infection.
- •- Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Exception: cholecystectomy is allowed.
- •- Estimated creatinine clearance (CrCl) < 60 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
- •- History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) during less than or equal to 12 months prior to the screening visit.
- •- Positive drug or alcohol test results at the screening visit or at check-in (Day -1) (may be repeated once, if a positive test was recorded in the first instance, at the discretion of the PI).
- •- Use of any systemically absorbed prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol (up to a maximum of 4 doses per day of 500-mg paracetamol, and no more than 3g per week).
- •- Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic re
研究者
相似试验
已完成
不适用
A 2-part, randomized, double-blind, placebo-controlled, sequential group, dose-escalation study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of GLPG2737 in healthy male sub.MucoviscidosisCystic fybrosis10027664NL-OMON42886Galapagos SAS112
已完成
1 期
A 2-part, randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of FTP 198 in healthy volunteersRespiratory - Other respiratory disorders / diseasesIdiopathic pulmonary fibrosisACTRN12620000181909Avance Clinical75
进行中（未招募）
1 期
A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverAutoimmune Hepatitis (AIH)MedDRA version: 20.0Level: PTClassification code 10003827Term: Autoimmune hepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2017-001555-32-ESovartis Farmacéutica S.A80
进行中（未招募）
1 期
A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverAutoimmune Hepatitis (AIH)MedDRA version: 20.1Level: PTClassification code 10003827Term: Autoimmune hepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2017-001555-32-DEovartis Pharma AG65
撤回
2 期
A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER)Autoimmun hepatitis10003816NL-OMON48945ovartis6