ACTRN12617001471370已完成1 期
A Single Center, Phase 1, Randomized, Open-Label Bioequivalence Trial in Healthy Volunteers Comparing ACP-011 Administered as a Single Dose via Syringe and Needle vs. Auto-Injector
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Male
入选标准
- •1) Healthy Male Adults aged between 18 and 65 years at time of informed consent
- •2) Body weight between 60.50 and 73.90 kg
- •3) Body mass index (BMI) between19 and 29 kg/m2
- •4) Considered to be in good general health at screening as determined by investigator
- •5) Able to comply with all protocol requirements.
- •6) Able to provide written informed consent.
排除标准
- •1) History of clinically significant (in the opinion of the investigator) endocrine disease; history or presence of endocrine tumors, thyroid disease, diabetes, or impaired glucose tolerance.
- •2) History of malignancy of any organ system (other than localized basal or squamous cell carcinomas of the skin), treated or untreated within the past 5 years.
- •3) Clinically significant (in the opinion of the investigator) history of neurological, cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease, glaucoma, a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- •4) On a 12-lead ECG, the subject has any of the following at screening, confirmed by repeat assessment:
- •- PR greater than or equal to 221 ms
- •- QRS greater than or equal to 120 ms
- •- QTcF greater than or equal to 451 ms
- •5) Systolic blood pressure <90 mmHg and >140 mmHg; diastolic blood pressure <40 mmHg and > 90 mmHg
- •6) Known or suspected HIV-positive status
- •7) Known or suspected infection with hepatitis B or C
- •8) Use of any prescription or over-the-counter medications (including herbal or nutritional supplements) within 14 days before the first dose of study drug.
- •9) Consumption of alcohol-containing products within 48 hours before dosing with study drug.
- •10) Social smokers who are otherwise healthy may be enrolled if they have not used nicotine containing products within 2 weeks prior to dosing.
- •11) History of alcohol or drug abuse
- •12) Strenuous activity or contact sports within 24 hours before dosing with study drug or during the study.
- •13) Donation of blood or blood products >450 mL within 30 days before dosing with study drug.
- •14) Presence of contraindications to hGH treatment
- •15) Known hypersensitivity to the components of the trial medication
- •16) Any medical abnormality unless approved by Medical Monitor
- •17) History of relevant drug and/or allergies (ie, allergy to ACP-011, or excipients, or any significant food allergy that would preclude a standard diet in the clinic).
- •18) Participation in drug trial in which receipt of a study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to study entry
- •19) Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule.
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