NCT00504907已完成1 期
A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial With BTA9881 in Healthy Subjects
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
- 63
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects.
研究概览
简要总结
This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects >=18 and <=45 years of age.
- •Individuals who have freely given Informed Consent in writing.
- •Male subjects should use appropriate contraception (e.g. condoms) during the time interval between dosing until three months after dosing. Female subjects must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicle-stimulating hormone (FSH) >18 mIU/mL and serum oestradiol <110 pmol/L), or must agree to use two forms of the following contraception: oral contraceptives, or other forms of hormonal birth control including hormonal vaginal rings or transdermal patches, intra-uterine devices, condoms, and spermicide during the time interval between dosing until three months after dosing. Female subjects must also be non-lactating and have a negative serum pregnancy test at screening and at baseline.
- •Able to perform nasal wash procedure.
- •Normotensive (systolic BP ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg).
- •No abnormal finding of clinical relevance at the screening examination that the Investigator considers might interfere with the objectives of this clinical trial.
- •No clinically relevant abnormality in the ECG; QTc <430 ms (males) or <450 ms (females).
- •Healthy based on medical history, physical examination, 12-lead ECG and clinical laboratory tests, and with no disease that the Investigator regards as clinically relevant.
- •Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
- •Willingness to abstain from alcohol and caffeine-containing food and beverages for 48 hours prior to dosing and for the duration of the clinical trial.
排除标准
- •Use of any prescription medication (other than allowable oral contraceptives and implanted hormonal contraceptives) during the 14 days prior to dosing.
- •Use of any non-prescription ('over the counter') product, including herbal products, diet aids, hormone supplements, etc., within 14 days prior to dosing.
- •Intake of any investigational drug within 3 months prior to dosing.
- •History or clinical evidence of significant cardiovascular disease (including risk factors for cardiac arrhythmias) or a previous history of any cardiovascular condition that, in the opinion of the investigator, would interfere with the conduct of the trial.
- •History or clinical evidence of significant cerebrovascular, cardiovascular, gastrointestinal, or haematological disease, or myocardial infarction, or a previous history of any other serious underlying disease (including immunocompromised subjects and/or neutropenic subjects) that, in the opinion of the investigator would interfere with the conduct of the clinical trial.
- •History or clinical evidence of significant respiratory disease (including asthma, chronic obstructive pulmonary disease, cystic fibrosis and/or recurrent lower respiratory tract infection), or upper respiratory tract infection within the last month or lower respiratory tract infection within the last three months.
- •History or clinical evidence of renal disease (including renovascular occlusive disease), nephrectomy and/or renal transplant, and/or previous clinically significant laboratory abnormalities of renal function parameters. All subjects with serum creatinine or proteinuria outside the normal laboratory reference range at screening and baseline that are regarded by the Investigator as clinically significant.
- •History or clinical evidence of hepatic disease and/or previous clinically significant laboratory abnormalities of liver function parameters. All subjects with bilirubin, gamma glutamyl transferase (GGT), alanine transaminase (ALT), and aspartate transaminase (AST) outside the normal laboratory reference range at screening and baseline, that are regarded by the Investigator as clinically significant. Subjects known to have experienced elevated liver enzyme values in previous clinical studies will also be excluded.
- •History or clinical evidence of adrenal disease (including Cushing's Syndrome or Addison's disease) or thyroid disease (including hyper or hypothyroidism), and/or previous clinically significant laboratory abnormalities of adrenal or thyroid function parameters. All subjects with thyroid function (TSH, FT4, FT3) outside the normal laboratory reference range at baseline and regarded by the Investigator as clinically significant.
- •Psychiatric or emotional problems that would invalidate the giving of Informed Consent or limit the ability of the subject to comply with clinical trial requirements.
- •Body Mass Index (BMI) ≤18.5 kg/m2 or >=30.0 kg/m
- •History of alcohol and/or drug abuse within 1 year prior to screening (verified by drug screening).
- •Receipt of blood or blood products, or loss of 450 mL or more of blood, during the last three months prior to dosing.
- •Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire clinical trial period.
- •Subjects who smoke or have been non-smokers for less than 3 months prior to dosing.
- •Subjects who were previously enrolled in this clinical trial.
- •Poor veins, or fear of venipuncture or sight of blood, or known allergy or hypersensitivity to lidocaine.
研究组 & 干预措施
Cohort A
Experimental
Placebo or BTA9881 -10mg
干预措施: BTA9881 (Drug)
Cohort A
Experimental
Placebo or BTA9881 -10mg
干预措施: Placebo (Drug)
Cohort B
Experimental
Placebo or BTA9881 - 10mg
干预措施: BTA9881 (Drug)
Cohort B
Experimental
Placebo or BTA9881 - 10mg
干预措施: Placebo (Drug)
Cohort C
Experimental
Placebo or BTA9881 - 25mg
干预措施: BTA9881 (Drug)
Cohort C
Experimental
Placebo or BTA9881 - 25mg
干预措施: Placebo (Drug)
Cohort D
Experimental
Placebo or BTA9881 - 50mg
干预措施: BTA9881 (Drug)
Cohort D
Experimental
Placebo or BTA9881 - 50mg
干预措施: Placebo (Drug)
Cohort E
Experimental
Placebo or BTA9881 - 100mg
干预措施: BTA9881 (Drug)
Cohort E
Experimental
Placebo or BTA9881 - 100mg
干预措施: Placebo (Drug)
Cohort F
Experimental
Placebo or BTA9881 - 200mg
干预措施: BTA9881 (Drug)
Cohort F
Experimental
Placebo or BTA9881 - 200mg
干预措施: Placebo (Drug)
Cohort G
Experimental
Placebo or BTA9881 - 400mg
干预措施: BTA9881 (Drug)
Cohort G
Experimental
Placebo or BTA9881 - 400mg
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects.
时间窗: Two weeks
次要结局
- To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects(Two weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy VolunteersPharmacokineticsHealthy VolunteersNCT02558413Biota Pharmaceuticals, Inc.60
终止
1 期
Escalating Single Dose Study of Epsi- Gam in Healthy Normal SubjectsAllergy and ImmunologyNCT02559258Tunitas Therapeutics, Inc.5
招募中
1 期
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy WomenVaginitisVaginal DiseaseBacterial InfectionsInfection, BacterialBacterial VaginosisNCT05587283AtoGen Co. Ltd24
已完成
1 期
A Trial of SHR-1819 in Healthy SubjectsHealthy VolunteersNCT04561128Atridia Pty Ltd.42
已完成
1 期
A Phase I Study of ICP-022 in Healthy SubjectsSystemic Lupus ErythematosusRheumatoid ArthritisNCT03189017Innocare Pharma Australia Pty Ltd64