ACTRN12622001077752尚未招募1 期
A Randomized, Single-Center, Partially Single-Blind Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Single and Repeated Doses of Oxytocin Administered via Inhalation or Intravenous or Intramuscular Administration in Healthy Female Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 16
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
- Prevention
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •1.Premenopausal women 18 to 45 years of age, inclusive.
- •2.Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and at admission to the study center.
- •3.Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study center.
- •4.Must be physically capable of using an oral inhalation dry-powder-inhaler device without physical assistance.
- •5.Must have FEV1.0 within normal range at screening and before the start of administration of each treatment.
- •6.Body weight not less than 45 kg and body mass index (BMI; weight kg/m2) within the range of 18 – 30 kg/m2 (inclusive).
- •7.Premenopausal woman:
- •All women must be of childbearing potential
- •8.All women must have a negative highly sensitive serum (human chorionic gonadotropin [hCG]) at screening and a negative urine pregnancy test on Day -1 (or on Day 1) of Dosing Session 1 and must not be lactating.
- •9.All women must be using two methods of contraception, including a combined estrogen-containing OCP for a 30-day minimum period before screening, and must be willing to continue using two methods of contraception, including their current OCP schedule, for the duration of the study and until completion of the follow-up visit.
- •10.A woman must agree not to donate eggs (ova, oocytes), or freeze for future use, for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last dosing day.
- •11.Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •Other Inclusions
- •12.Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
排除标准
- •1. History of or current clinically significant medical illness
- •2. Chronic lung condition of any aetiology including adult asthma, chronic obstructive pulmonary disease (COPD), emphysema, bronchospastic respiratory disease and interstitial lung diseases.
- •3. Underlying cardiovascular diseases (including hypertrophic cardiomyopathy, valvular heart disease, and/or ischemic heart disease including coronary artery vasospasm).
- •4. Previous or current clinical history of proven pulmonary or systemic tuberculosis.
- •5. Proven or suspected respiratory tract infection / pneumonia of any aetiology within 4 weeks of screening.
- •6. History of pulmonary embolus, pulmonary hypertension of any aetiology, and peripheral venous thromboembolism.
- •7. Use of an intrauterine device (IUD) within last 3 months prior to screening.
- •8. Any pregnancy within the last 12 months prior to screening.
- •9. Gynecological disorders or other diseases which can increase the risk of pelvic fibrosis.
- •10. Alanine transaminase (ALT) [or aspartate transaminase (AST)] >1.5 x upper limit of normal (ULN).
- •11. Total bilirubin >1.5 x ULN (isolated total bilirubin >1.5 x ULN is allowed for those participants with known Gilbert’s syndrome; Gilbert’s syndrome is suggested by direct bilirubin <30%).
- •12. Current or chronic history of liver disease.
- •13. Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •14. Known allergies, hypersensitivity, or intolerance to IH oxytocin or oxytocin injection, or their excipients.
- •15. History of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation such as – allergy to latex; allergy to any previous inhaler use.
- •16. Contraindications to the use of oxytocin injection per local prescribing information
- •17. Taken any disallowed therapies before the planned first dose of study intervention.
- •18. Received an investigational intervention, including investigational vaccines, or used an invasive investigational medical device within 1 month or within a period less than 5 times the drug’s half-life, if known, whichever is longer, before the planned first dose of study intervention, or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the planned study intervention. In case the half-life of the biological product is not known, the exclusion window will be 6 months before the first dosing day.
- •19. Is currently enrolled in an investigational study.
- •20. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- •21. Had major surgery, (eg, requiring general anesthesia) within 3 months before screening (if fully resolved with no further follow up required), or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 60 days after the last dose of study intervention administration.
- •22. Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening.
- •23. Presence of hepatitis B surface antigen (HBsAg) [or hepatitis B core antibody (HBcAb)] at screening or within 3 months prior to first dose of study intervention.
- •24. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- •25. History of hepatitis A within 3 months prior to screening or current hepati
研究者
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