ISRCTN15115094已完成1 期
A randomised, double-blind, placebo-controlled, repeat dose phase 1b study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of Inhaled GSK3923868 during experimental human rhinovirus infection in participants with asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
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
- 性别
- All
入选标准
- •1. Age between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- •2. Type of Participant
- •2.1. A physician diagnosis of asthma, as defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiratory airflow limitation [Global Initiative for Asthma (GINA), 2021] at least 6 months before Screening.
- •2.2. The criteria for diagnosis of asthma should be documented in the participant’s source data, including relevant history.
- •2.3. A screening pre-bronchodilator FEV1 =65% predicted normal value.
- •2.4. Positive Methacholine challenge test, defined as =20% fall in FEV1 at a methacholine concentration =16 mg/mL, at Screening Visit.
- •2.5. Positive skin prick test to at least one allergen (e.g. house dust mite, cat dander, grass pollen) at Screening Visit.
- •2.6. Serology suitable for the challenge virus:
- •2.7. The serology results obtained from the HRV-16 neutralisation antibody assay suggests that the participant will be susceptible to HRV-16 infection (i.e. they are likely to be infected following inoculation with the challenge virus).
- •2.8. Participants with controlled asthma, according to Investigator judgement, using short-acting beta agonist (SABA) or intermittent inhaled corticosteroid (ICS) or ICS/long-acting beta agonist (LABA) therapy used as rescue.
- •3. Body weight at least 50.0 kg (110 lbs) and body mass index (BMI) within the range 18.5 to 34.0 kg/m² (inclusive).
- •4.1. Males and female participants, as follows:
- •4.2. Male Participants: No additional requirements.
- •4.3. Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is a woman of non-childbearing potential (WONCBP) as defined in the protocol OR
- •Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as described in the protocol during the intervention period and for at least 28 days after inoculation. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated in relationship to the first dose of study intervention). A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 48 hours before the first dose of study intervention or Viral Challenge (whichever occurs first).
- •Note: If a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
排除标准
- •1. Medical Conditions
- •1.1. Any asthma exacerbation requiring systemic corticosteroids within 8 weeks of admission, or that resulted in overnight hospitalization requiring additional treatment for asthma within 3 months of admission
- •1.2. A history of life-threatening asthma, defined as any asthma episode that required admission to a high-dependency or intensive therapy unit.
- •1.3. The presence of concurrent significant pulmonary diseases, other than asthma, including (but not limited to): bronchiectasis, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other significant respiratory abnormalities.
- •1.4. The presence of other concurrent diseases/abnormalities that, in the opinion of the Investigator, would put the safety of the participant at risk or would confound the interpretation of the results in this study.
- •1.5. Please Note: participants with a history of resolved mild depression and/or anxiety 1 or more years ago may be included if the patient health questionnaire(PHQ-9) and/or the generalised anxiety disorder questionnaire (GAD-7) is less than or equal to 4 on admission to the clinical unit. Participants with a history of stress-related illness, which is not on-going or requiring current therapy, with good evidence of preceding stressors may also be included based on Investigator’s judgement.
- •1.6. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may, in the Investigator’s judgement, interfere with the aims of the study.
- •1.7. Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of admission and/or history of being hospitalised due to epistaxis on any previous occasion.
- •1.8. Any nasal or sinus surgery within 3 months of admission.
- •1.9. Has had any acute illness, including a common cold or other respiratory tract infection, within 6 weeks before admission to the unit.9.Has had any major illness or hospitalisation within 6 months before admission to the unit.10.ALT above 1.1 x upper limit of normal (ULN)
- •1.10. Lifetime history of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the Investigator.
- •1.11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •1.12. QTcF >450 msec on Day -1based on the average of triplicate ECGs.
- •2. Prior/Concomitant therapy
- •2.1. Past or intended use of over-the-counter or prescription medication, including (but not limited to) nasal decongestants, cold remedies, herbal and dietary supplements (including St John’s Wort; vitamins are allowed) within 5days before the Viral Challenge or first dose of study intervention (whichever occurs first), unless in the opinion of the Investigator and the GSK Medical Monitor, the medication will not interfere with the study objectives or compromise participant safety.
- •2.2. Evidence of vaccinations within the 4 weeks prior to the planned date of Viral Challenge or first dosing with IMP (whichever occurs first).
- •2.3. Intention to receive any vaccination(s) before the last day of Follow Up.
- •3. Prior/Concomitant clinical study experience
- •3.1. Participation in this study would result in loss of blood or blood products in excess of 500mL within 56 days.
- •3.2. Exposure to more than 4 new chemical entities within 12 months before the first dosing day.
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