A phase I, placebo controlled, dose escalation safety andpharmacokinetic study of Topical Endoxifen in healthy male volunteers.

Atossa Genetics, Inc.0 个研究点目标入组 24 人开始时间: 2018年4月13日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•1. Healthy adult males, 18 to 65 years of age (inclusive) at the time of screening;
•2. Body Mass Index (BMI) within the range of 18 to 32 kg/m2 inclusive at screening;
•3. Absence of significant diseases which, at the physician's discretion, could have an impact on the volunteer's participation in the trial,
•4. Medically healthy without clinically significant abnormalities at the screening visit or Day -1,
•5. Screening laboratory tests that are deemed to be non-clinically significant by the investigator;
•6. Negative cotinine, drug and alcohol tests at screening and check in;
•7. Ability to understand the nature and objectives of the trial
•8. Participants with partners of child-bearing potential must agree to use condom and one
•of the following contraceptive methods:
•a. Complete abstinence from intercourse during the dosing with study drug through the End-of-Study and at least 60 days after the conclusion of study drug administration; OR
•b. The female partner must be using effective contraception such as hormonal, IUD, a double-barrier method, or is sterilized; OR
•c. Sterilization (vasectomy);
•9. Have no air travel commitments during the study and for four weeks following completion of the study treatment;
•10. Have suitable venous access for blood sampling;
•11. Willing and able to comply with the requirements of the study protocol.

•1. History or presence of a clinically significant disorder including but not limited to: cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease, including any acute
•illness or surgery within the past three months determined by the PI to be clinically relevant;
•2. History of drug addiction, including alcohol within 1 year;
•3. Smokes or uses e-cigarettes;
•4. Have a hypersensitivity or allergy to the investigational compound;
•5. Treatment, within 3 months before the trial, with any drugs known to have a well-established toxic potential to major organs;
•6. Have participated in any other investigational study within 30 days or 5 half-lives of the drug (whichever is longer) of screening;
•7. Use of any medications or over the-counter products within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication;
•8. Have any history or evidence of procoagulant disorder, Deep Vein Thrombosis (DVT) or pulmonary embolism;
•9. Donation of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrolment.
•10. Any conditions, that according to investigator's best judgment, prevent participation in the trial.

发起方

Atossa Genetics, Inc.