ISRCTN79552451进行中（未招募）1 期
A Phase I, adaptive, open-label, single ascending dose to single-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mRNA-0184 in participants with chronic heart failure
Moderna France0 个研究点目标入组 98 人开始时间: 2022年10月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 98
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 =18 years at the time of informed consent
- •2. Documented diagnosis of HF based on medical records
- •3. Left ventricular ejection fraction (LVEF) =35% and <50% at Screening, or documented within the 3 months before Screening, measured by TTE or cardiac magnetic resonance imaging (MRI)
- •4. New York Heart Association (NYHA) HF Class I or II
- •5. On a stable regimen of cardiovascular medication(s) for a duration of at least 4 weeks before Screening
- •6. Heart rate =50 bpm at Screening
- •7. Systolic blood pressure =110 mmHg and =160 mmHg at Screening
- •8. Sexually active female participants of childbearing potential and sexually active male participants of reproductive potential agree to use a highly effective method of contraception during the study and for 6 months after the last administration of IP
排除标准
- •1. Hospitalized for cardiovascular causes within 3 months before Screening
- •2. Decompensated HF, acute myocarditis, hypertrophic and/or restrictive/constrictive cardiomyopathy, or moderate or severe valvular heart disease (as classified by echocardiography) at Screening or within the 3 months before Screening. Moderate tricuspid regurgitation is not exclusionary
- •3. Symptoms of angina pectoris at Screening
- •4. Severe obstructive or restrictive pulmonary pathology, including chronic obstructive pulmonary disease Gold Stage III or IV current use of oxygen therapy, or pulmonary hypertension
- •5. History of sustained ventricular tachycardia or atrial fibrillation/atrial flutter with a ventricular response =110 bpm at the time of Screening
- •6. Severe renal impairment defined as one or both of the following:
- •6.1. Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m², calculated using the Simplified Modification of Diet in Renal Disease equation
- •6.2. Current or planned dialysis or ultrafiltration
- •7. Prolonged QTcF >450 ms at Screening
- •8. Laboratory abnormality within an exclusionary threshold at Screening
- •9. For female participants, positive pregnancy test at Screening or Baseline or currently breastfeeding
- •10. Hypersensitivity to acetaminophen/paracetamol or H1-receptor or H2-receptor blockers
- •11. History of hypersensitivity to any components of the IP
- •12. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B surface antigen [HBsAg] result), hepatitis C virus (HCV), or HIV (positive HIV-1/HIV-2 antibodies). Participants with a past or resolved hepatitis virus B (HBV) infection(defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acids (RNA)
- •13. Participant has received a COVID-19 vaccination (irrespective of type of vaccine) or is anticipated to require a second dose of a two-dose COVID-19 vaccine series within 7 days of the planned date of IP administration
- •14. For SAD cohort participants to be rolled over into the MAD stage, have experienced a DLT in a SAD cohort
- •15. Participation in another clinical study of another IP within 30 days before Screening or within 5 effective elimination half-lives of the IP, whichever is longer
- •16. Has a positive urine drug screen for any of the following nonprescription drugs of abuse at Screening: alcohol, opiates, cocaine, phencyclidine, amphetamines, methamphetamines, barbiturates, benzodiazepines, or methadone. Positive drug screens for benzodiazepines or opiates will not be exclusionary if prescribed concomitant medications can justify the result
- •17. Any other clinically significant medical condition that, in the Investigator’s opinion, could interfere with the interpretation of study results or limit the participant’s participation in the study
研究者
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