NL-OMON49803撤回2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP) - EDP 938-102
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 8
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. A full ICF signed and dated by the subject. (Note: Prior to signing the full
- •ICF, subjects will sign a Rapid Viral Screen ICF as described in inclusion
- •criterion #4.)
- •2. Male or female individuals aged 18 to 75 years, inclusive.
- •3. Up to 48 hours of URTI symptoms with at least one of the following symptoms:
- •Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus
- •congestion, sneezing, sore throat, hoarseness, cough, shortness of breath,
- •respiratory wheeze, earache, and/or symptoms of fever.
- •Note: The duration of symptoms (not more than 48 hours) is to be measured from
- •the estimated time of onset of the first symptom.
- •4. After signing the Rapid Viral Screen ICF, positive for RSV infection and
- •negative for influenza virus based on rapid diagnostic screen of nasal (or
- •nasopharyngeal) swab samples.
- •5. Medically stable based on assessment of physical examination, medical
- •history, vital sign measurements, pulse oximetry (only for subjects with asthma
- •or COPD), and 12-lead ECG performed at Screening.
- •6. A body mass index >=18 kg/m2 and <=40 kg/m2.
- •7. Negative urine pregnancy test for women of childbearing potential as defined
- •in inclusion criterion #8.
- •8. A woman of childbearing potential who is sexually active with a male must
- •agree to use two effective methods of contraception from the date of Screening
- •until 30 days after her last dose of study drug. Effective methods of
- •contraception are defined as:
- •A condom for the male partner and at least one of the following for the female
- •a. Intrauterine device
- •b. Occlusive cap (diaphragm or cervical/vault caps)
- •c. Oral, injectable, implantable, transdermal, or intravaginal hormonal
- •contraceptive
- •Note: The above does not apply to a female subject who has a vasectomized male
- •as the sole partner or who is of nonchildbearing potential (ie, physiologically
- •incapable of becoming pregnant) as defined below:
- •a. Has had a complete hysterectomy >=3 months prior to dosing or
- •b. Has had a bilateral oophorectomy (ovariectomy) or
- •c. Has had a bilateral tubal ligation or fallopian tube inserts or
- •d. Is postmenopausal (a total cessation of menses for at least 2 years; Note:
- •Subjects with a cessation of menses between 1 to 2 years and a
- •follicle-stimulating hormone [FSH] level of >35 mIU/mL will also be
- •considered to be postmenopausal).
- •9. A male subject who has not had a vasectomy and is sexually active with a
- •woman of childbearing potential must agree to use effective contraception from
- •the date of Screening to 90 days after his last dose of study drug. Effective
- •contraception is defined as a condom and at least one of the following for a
- •female partner:
- •a. Intrauterine device
- •b. Occlusive cap (diaphragm or cervical/vault caps)
- •c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive
- •Note: For a male subject who has had a vasectomy, use of a condom will still be
- •10. Male subjects must agree to refrain from sperm donation from the date of
- •Screening until 90 days after his last dose of study drug.
- •11. Must be willing and able to adhere to the study assessments, visit
- 另有 3 项未显示
排除标准
- •1. Clinical evidence of a lower respiratory tract infection, as determined by
- •the Investigator.
- •2. Anticipated need for hospitalization or emergency room care within 24 hours
- •of Screening.
- •3. Receipt of systemic antiviral, antibacterial, antifungal, or
- •antimycobacterial therapy within 7 days of Screening and for the duration of
- •4. Awareness of concomitant respiratory infections that are viral (other than
- •RSV), bacterial, or fungal, including systemic bacterial or fungal infections,
- •within 7 days of Screening.
- •5. SARS-CoV-2 positive within 28 days of Screening or at Screening following
- •signature of full ICF.
- •6. Frailty scale score >=4 at Screening.
- •7. History of chronic liver disease (eg, hemochromatosis, Wilson*s disease,
- •alpha-1 antitrypsin deficiency, autoimmune hepatitis, nonalcoholic
- •steatohepatitis, and/or alcoholic liver disease); a history of biliary disease
- •(eg, primary sclerosing cholangitis, cholecystitis, choledocholithiasis); or a
- •history of portal hypertension. A diagnosis of hepatic steatosis (fatty liver)
- •is not exclusionary.
- •8. Heart disease: any congenital heart disease, acute or chronic heart failure,
- •ischemic heart disease, congenital long QT syndrome, or any clinical
- •manifestation resulting in QT interval prolongation. Note: Subjects with
- •controlled hypertension without cardiac compromise will be allowed to enroll.
- •See exclusion criterion #18 for prohibited medications.
- •9. Neurological and neurodevelopmental disorders (including disorders of the
- •brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy
- •[seizure disorders], stroke, muscular dystrophy, or spinal cord injury). Note:
- •Minor neurological disorders (eg, past concussions, headaches, migraine) are
- •10. Malignant tumor or history of malignancy that may interfere with the aims
- •of the study or a subject completing the study.
- •11. Prior receipt or the subject is waiting to receive a bone marrow, stem
- •cell, or solid organ transplantation.
- •12. Diagnosis of cystic fibrosis.
- •13. Known positive human immunodeficiency virus, active hepatitis A virus
- •infection, chronic hepatitis B virus infection, and/or current or treated
- •hepatitis C virus infection.
- •14. Prior or planned ileal resection or bariatric surgery. Note: Subjects who
- •have undergone gastric surgeries that do not affect drug absorption (eg,
- •gastric band or gastric sleeve procedures) will be allowed to participate if
- •they are stable for at least 1 year prior to
- •Screening. Gastrectomy will be allowed if stable for at least 3 years prior to
- •15. Pregnant or nursing female subjects.
- •16. History of alcohol addiction or current heavy alcohol use defined as: >14
- •standard drinks per week and/or >=4 standard drinks per occasion for males and
- •>7 standard drinks per week and/or >=3 standard drinks per occasion for females.
- •A standard drink is 12 oz of beer (5% alcohol), 5 oz table wine (12% alcohol),
- •or 1.5 oz of spirits (40% alcohol).
- •17. Known or suspected, in the opinion of the Investigator, renal disease or
- •renal impairment.
- •18. Twelve-lead ECG demonstrating a QT interval corrected for heart rate
- •according to Fridericia (QTcF) that is >500 msec or other clinically relevant
- 另有 2 项未显示
研究者
相似试验
撤回
2 期
A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis [VIBRATO]moderate to severe ulcerative colitis10018027NL-OMON48602Pfizer5
撤回
2 期
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)NL-OMON48943Hookipa Biotech AG22
撤回
不适用
A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infectiorespiratory tract infectionRespiratory syncytial virus infectionNL-OMON43180Janssen Science Ireland UC3
撤回
3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a TriggerNL-OMON51930PPD4
撤回
2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac SurgeryNL-OMON55701Allergan Ltd.30