A Phase 1, Double-blind, Single Center, Controlled Study to Evaluate the Safety and Tolerability of FSR Peptide Versus Placebo Following Punch Biopsy in Adult Healthy Volunteers

Xequel Bio, Inc.1 个研究点分布在 1 个国家目标入组 49 人开始时间: 2008年3月6日最近更新: 2020年7月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Xequel Bio, Inc.
入组人数: 49
试验地点: 1
主要终点: Frequency of adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female healthy subjects, 18-45 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
•Female subjects must have been surgically sterilized at least six months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. OR: Postmenopausal women must have no regular menstrual bleeding for at least two years prior to inclusion. Menopause was to be confirmed by a plasma 17β-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L.
•Normal sitting blood pressure and pulse rate , i.e.: BP: 100 - 140 mm Hg systolic, 50 - 90 mm Hg diastolic and pulse rate: 45 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.
•Subject body mass index between 18 and 30 kg/m2
•Ability to communicate well with the investigator and comply with the requirements of the entire study.
•The subject has given his written consent to participate in the study.

排除标准

•History of serious adverse reactions or hypersensitivity to any drug.
•Presence or history of any allergy requiring acute or chronic treatment (seasonal) allergic rhinitis which requires no treatment may be tolerated).
•History of alcohol or drug abuse in the last 3 years.
•Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
•Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study.
•Participation in a clinical trial during the previous 4 weeks, i.e. from completion of the previous trial to the planned first administration of the current trial.
•Loss of 500 ml blood or more during the 3 month period before the study, e.g. as a donor.
•Existence of any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
•Symptoms of a significant somatic or mental illness in the two week period preceding drug administration.
•History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
•Positive results from the HIV serology.
•Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation. Serum albumin below 3.5 g/l (Note to File no. 8 states that the correct albumin value is below 35g/l) precludes study inclusion in any case.
•History of serious mental disorders.
•Positive results of the drug screening.
•History or clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic or other disease.
•Presence of any active skin pathology including e.g., acne, acute sunburn, inflammatory skin disease.
•Presence of any open wounds or infection on the same arm.
•History of skin disorders e.g. atopic eczema or psoriasis or keloid reaction(s) Any condition that constitutes a contraindication to minor surgical procedures (such as bleeding disorders) or that obliges to the use of prophylactic antibiotics (such as mitral valve prolapse) or other comedications for the performance of minor surgical procedures.