EUCTR2007-006741-40-DE进行中（未招募）不适用
A double blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety, tolerability and immunogenicity of repeated s.c administrations of 100µg NIC002 vaccine in cigarette smokers who are motivated to quit smoking
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Healthy male and female smoking subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, spirometry and laboratory tests at screening. Subjects with medically managed hypertension or hypercholesterolemia may be included in the study.
- •2.Subjects must be smoking 10 or more cigarettes per day during the past 12 month prior to the week 0, with no period of abstinence longer than 7 days in the last 3 months prior to week 0.
- •3.The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening.
- •4.The Fagerström Test for Nicotine Dependence (FTND) should indicate at least a moderate level of nicotine dependence which is a score of 5 or above at screening.
- •5.Subjects must agree to quit smoking by TQD.
- •6.At screening vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three (3) minutes, Investigators can be guided by the following ranges:
- •systolic blood pressure, 90-140 mm Hg
- •diastolic blood pressure, 50-90 mm Hg
- •pulse rate, 45 - 100 bpm
- •7.Female subjects must be postmenopausal with no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening.
- •Female subjects must have been surgically sterilized at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than six (6) months prior to first dosing.
- •8.Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three (3) months following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
- •9.Subjects must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
- •10.Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Attempted to quit smoking in the three (3) months prior to week 0.
- •2.Use of smoking cessation aid, i.e. nicotine replacement therapy (NRT), bupropion, clonidine, nortryptiline or varenicline in the previous 3 months. Use of any other nicotine vaccine prior to the study. Use of NRT products during the study which are available OTC must be discouraged. Subjects using NRT can stay in the study. Use of NRT will be specifically checked by the investigator and documented on the NRT eCRF page.
- •3.Use of any other vaccine based on the Qbeta virus like particle.
- •4.Any surgical or medical condition which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
- •History of autoimmune or immunological disorders, immune deficiency. ANA at screening with a titer in the abnormal range for the lab (generally > 1:40).
- •History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- •Significant cardiovascular disease including but not limited to angina pectoris, congestive heart failure, uncontrolled arterial hypertension, clinically significant heart murmurs, clinical significant arrhythmia or previous angioplasty or coronary artery bypass surgery
- •Significant hepatic disease.
- •Significant renal disease, i.e. history or laboratory findings indicating renal impairment.
- •Significant hematological disorder.
- •Significant pulmonary disease.
- •History of malignancy (excluding non-melanoma skin cancer and cured cervical cancer).
- •Organic neurological disorder or significant psychiatric disorder, especially presence of symptoms of depression or history of clinically significant depressive episodes during the last 10 years, and only if medical treatment for more than one month was required.
- •Women who are of child bearing potential, pregnant or breast feeding.
- •Individuals with high occupational aluminium exposure for example during aluminium manufacturing.
- •Donation or loss of 400 ml or more of blood within four (4) weeks prior to initial dosing, or longer if required by local regulation.
- •Significant acute illness or surgery within two (2) weeks prior to initial dosing.
- •5.Concomitant medications for acute conditions at the time of screening are excluded – the inclusion of a subject into the study must be deferred until the condition is resolved and the acute medication terminated. Use of any concomitant medication which contains aluminium for example antacids, some aspirin preparations are not permitted. Any other medication that has been received in a stable manner will be allowed and must be documented in the CRF (e.g. anti-hypertensives and cholesterol lowering medication).
- •6.Use of psychoactive drug (excluding sleeping pills) within one month before enrolment
- •7.Any planned surgical intervention during the study period (excluding surgical intervention for minor procedures and only if ambulatory).
- •8.Participation in any clinical investigation within eight (8) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •9.History of a positive HIV (ELISA and Western blot) Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
- •10.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of s
研究者
相似试验
尚未招募
2 期
Safety and efficacy trial of whey growth factor extract for oral mucositisOral mucositis in lymphoma patientsCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaACTRN12606000083594TGR Biosciences60
进行中（未招募）
1 期
The purpose of this phase II placebo controlled study is to assess the safety and efficacy on conjunctival provocation test (CPT) of different short courses of PQ Birch treatment, as part of the clinical development programme of this product.Seasonal allergic rhinoconjunctivitis due to birch pollenMedDRA version: 18.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853EUCTR2015-000984-15-DEAllergy Therapeutics (UK) Ltd350
进行中（未招募）
不适用
The purpose of this phase II placebo controlled study is to assess the safety and efficacy on conjunctival provocation test (CPT) of different short courses of PQ Birch treatment, as part of the clinical development programme of this product.Seasonal allergic rhinoconjunctivitis due to birch pollenMedDRA version: 18.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853EUCTR2015-000984-15-ATAllergy Therapeutics (UK) Ltd350
进行中（未招募）
不适用
A double-blind, placebo-controlled, multicentre study with an open-label extension to evaluate the efficacy and safety of tetrahydrobiopterin (BH4) in children and adolescents with hyperphenylalaninemia caused by phenylalanine hydroxylase deficiencyHyperphenylalaninemia due to phenylalanine hydroxylase deficiency. Phenotypes: classic phenylketonuria (PKU), mild PKU (MPK) or mild hyperphenylalaninemia (HPA).MedDRA version: 81Level: LLTClassification code 10034873EUCTR2006-000648-15-ATORPHANETICS Pharma Entwicklungs- GmbH75
已完成
2 期
An oral killed non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with mild to moderate airways disease: Safety and efficacy studyAcute bronchitis in mild to moderate airway diseaseRespiratory - Other respiratory disorders / diseasesACTRN12606000076572Hunter Immunology Ltd124