ISRCTN36174912已完成1 期
Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of Ascending Doses of ENTR-601-44 in Healthy Male Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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
- Male
入选标准
- •1. Male participants aged 18 to 55 years, inclusive, at Screening.
- •2. Body mass index (BMI) within the range of 18.0 to 32.0 kg/m², inclusive, and a minimum weight of 50.0 kg at Screening.
- •3. Healthy, in the opinion of the Investigator, based on medical history, physical examination, vital signs, and 12-lead ECG at Screening.
- •4. Clinical laboratory test results within the laboratory reference range at Screening; or, if out of range, were not clinically relevant and were acceptable to the Investigator.
- •5. Negative for drugs of abuse and alcohol tests at Screening and at admission on Day -1.
- •6. Participants with female partners who are of childbearing-potential must agree to use a highly effective method of contraception (e.g., hormonal contraception) for the duration of the study.
- •7. Participants able to speak, understand, read, and write English fluently to understand the nature of the study, provide written informed consent, and allow for the completion of all study assessments.
- •8. 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.
- •9. Participants willing and able to abide by all study requirements and restrictions.
排除标准
- •1. Current or prior history of any of the following:
- •a. Any illness or medical disorder or currently under evaluation for an illness or medical disorder.
- •b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- •c. History of solid organ transplantation.
- •d. Malignancy within the 5 years prior to Screening with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Participants under evaluation for possible malignancy are not eligible.
- •e. History of significant drug allergy, such as anaphylaxis.
- •f. History of renal disease, including recurrent urinary tract infections.
- •g. Any personal or first-degree family history of genetic kidney disease.
- •2. Screening ECG with clinically significant abnormalities (arrhythmias, PR > 220 msec, QRS complex > 120 msec, QT interval corrected for heart rate using Fridericia’s method [QTcF] > 450 msec).
- •a. If the ECG is out of range, the Investigator may obtain 2 additional triplicate readings, so that up to 3 consecutive assessments are made. If the ECG data are out of range at each of these 3 consecutive assessments or based on the mean of the 3 readings, the participant is not eligible
- •for study participation.
- •3. Known family history or known presence of long QT syndrome.
- •4. Clinically relevant hypertension (systolic blood pressure [BP] > 140 mmHg and/or diastolic BP > 90 mmHg, and heart rate > 100 bpm) at the time of Screening.
- •a. BP may be repeated as a triplicate up to 2 additional times. If individual values are outside the reference range at each of these 3 consecutive assessments or based on the mean of the 3 readings, the participant is not eligible for study participation.
- •5. eGFR <90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration
- •(CKD-EPI) Cystatin C Equation at the time of Screening.
- •6. Clinical diagnosis of diabetes (glycated hemoglobin [HbA1c] > 6.5%) at the time of Screening.
- •7. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)-1 and -2 tests at Screening.
- •8. A positive COVID-19 test at the time of Screening or Day -1.
- •9. Participants receiving any prescription, over-the-counter, or herbal medications in the 14 days prior to Day -1.
- •10. Participants who have received any agents with nephrotoxic potential in the 30 days prior to Day -1.
- •11. Participants that used an investigational drug in any clinical trial within 30 days or 5 half-lives, whichever is longer, of Day 1.
- •12. Participants that have previously received exon skipping therapy.
- •13. Participants with prolonged coagulation times at the time of Screening, and/or participants with any contraindications to needle muscle biopsy, including history of keloid scarring, bleeding disorders, use of anticoagulants, or routine use of aspirin per the Investigator’s discretion.
研究者
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