A Phase 1, Randomized Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intermittent Consecutive Day Dosing Regimen of PRTX007 in Healthy Volunteers

nited States Defense Threat Reduction Agency (DTRA)0 个研究点目标入组 15 人开始时间: 2024年8月12日最近更新: 2024年8月19日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 15

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment

入排标准

年龄范围: 18 Years 至 65 Years（—）
性别: All

入选标准

•Aged between 18 and 65 years of age at time of consent
•- Male or female and meet the following conditions:
•a. Female participants must be of non-child-bearing potential, defined as absence of
•menses for at least 1 year prior to dosing (without an alternative medical condition); and
•FSH levels greater than or equal to 40 mIU/mL at screening; or,
•b. If of child-bearing potential, be non-pregnant or lactating and agree to use highly
•effective contraception from screening through 30 days post final dose.
•c. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with
•a female partner of child-bearing potential, must be willing to use highly effective
•contraception from screening through 90 days post final dose and agree not to donate
•sperm during this period.
•d. Highly effective contraception involves the use of a condom for the male, plus one of
•the following for the female:
•i. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
•ii. Intrauterine device or intrauterine hormone-releasing system
•e. Participants who do not engage in heterosexual intercourse will be considered
•abstinent and do not require contraception. Abstinence must be an ongoing and usual
•lifestyle of the participant and complete abstinence must be maintained from screening
•through 30 days post final dose.
•- Is judged to be in good health based on medical history, physical examination, vital sign
•measurements, and laboratory safety tests performed at the screening visit and/or
•before the first dose of study drug.
•- Weigh at least 45kg at the time of screening
•- Have a body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2 at the time of screening
•- Have suitable venous access for blood sampling
•- Negative SARS-CoV2 test if required per site standards
•- Agrees to be available for all study visits and cooperate fully with the requirements of the
•study protocol, including the schedule of assessments
•- Willing to refrain from over-the-counter (OTC) or prescription medications or herbal,
•nutritional or dietary supplements from 7 days or 5 half-lives of the drug (whichever is
•longer) before first dose through the final follow-up visit, except for limited use of
•paracetamol (up to 2g per day for no more than 3 consecutive days), ibuprofen (up to
•1.2g per day for no more than 3 consecutive days), oral all forms of contraceptive
•medication or in the case of necessary treatment of adverse events (AEs). These limits
•do not apply to its use for the necessary medical treatment of adverse events.
•- Willing to refrain from alcohol and caffeine from 48 hours before first dose through the
•last dose of study drug
•- Subjects who smoke no more than 5 cigarettes or equivalent per week can be included
•in the study but must be willing to abstain from smoking during the confinement period.
•- Willing and able to provide written informed consent

排除标准

•- Has an active malignancy, or history of malignancy, excluding basal or squamous cell
•carcinoma of the skin, within 2 years prior to screening
•- History of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but
•not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac
•arrhythmia, hypertension, hypotension, or tachycardia. Clinically significant screening
•values measured after 5 minutes of rest in a supine or semi-supine position include:
•a. Abnormal systolic blood pressure (<90 or > 150 mmHg)
•b. Abnormal diastolic blood pressure (<40 or > 95 mmHg)
•c. Abnormal respiratory rate (<10 or > 22 bpm)
•The resting time may be extended as needed to accommodate clinical activities and may be repeated twice.
•- Has a clinically significant history or presence of electrocardiogram (ECG) findings as
•judged by the PI or designee at screening, including:
•a. Abnormal sinus rhythm (heart rate <40 bpm or > 100 bpm);
•b. Average QT interval corrected using Fridericia’s formula (QTcF) interval duration
•> 450 msec
•c. Average QRS interval > 120 msec after being confirmed by manual over-read
•d. Average PR interval > 220 msec
•- Has clinically significant laboratory abnormalities including:
•a. Impaired renal function (serum creatinine levels >106 µmol/L) at screening.
•b. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) laboratory
•values >1.5X upper normal limits.
•c. Subject has an estimated creatinine clearance of <80 mL/min as determined by the
•Cockcroft-Gault equation. Laboratory screening can be repeated upon investigator
•discretion.
•- History of prescription drug abuse or in the opinion of the investigator illicit drug use
•within 6 months prior to screening
•- Use of any vaccines within 14 days prior to first dose administration on Day 1.
•- History of moderate or severe psychiatric illness, based on physician’s judgment
•- History of alcohol abuse defined as regular consumption of more than 10 standard
•alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day,
•where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9%
•Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]) within 5 years prior to
•- Positive alcohol breath test or urine test for drugs of abuse. May be repeated at the
•investigator’s discretion.
•- Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C
•virus antigen, and anti-human immunodeficiency virus (HIV) type 1 antibody
•- Has received treatment with another investigational drug, investigational device, or
•approved therapy for investigational use within 30 days or 5 half-lives (whichever is
•longer) prior to dosing; prior participation at any time in non-invasive methodology trials
•in which no drugs were given is acceptable.
•- Has donated blood or plasma within 30 days prior to screening, or had a loss of whole
•blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood
•transfusion within one year prior to screening
•- Has experienced symptoms of acute illness or chronic disease within 14 days prior to
•screening, or any disease or condition (medical or surgical) that, by t

研究者

发起方

nited States Defense Threat Reduction Agency (DTRA)

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