A Double Blind, Ascending Multiple Dose Study to Evaluate the Safety and Tolerability of GAL-021 in Healthy Volunteers. - An Ascending Multiple Dose Study of GAL-021.

Galleon Pharmaceuticals, Inc0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Galleon Pharmaceuticals, Inc
入组人数: 36

研究概览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

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
•2. The subject is female or male >=30 to <=60 years of age.
•3. Subject must weigh >=70 to <=120 kg.
•4. Subjects must have Body Mass Index [weight/height^2 (kg/m^2)] between 25 to 35 kg/m2.
•5. Female subjects must be:
•a. Postmenopausal (defined as 12 months with no menses, with an estradiol < 30 pmol/L) and FSH concentrations compatible with being postmenopausal.
•b. Surgically sterilized at least 3 months prior to baseline (e.g., documented hysterec-tomy or tubal ligation) with a negative serum β-hCG.Non-lactating and non-breastfeeding prior to and 1 year following study completion.
•c. Premenopausal and if unsterilized must have used a medically accepted method of contraception for 3 months (or abstained from sexual intercourse) prior to the screening period, and agree to use a medically accepted method of contraception during the trial (including the screening period prior to receiving trial medication) and for 2 months after stopping the trial medication. An acceptable method of contraception includes one of the following:
•I. stable oral, transdermal, injectable, or sustained-release vaginal hormonal contraceptive regimen without breakthrough uterine bleeding for 3 months prior to screening; in addition, during the study use of condom and/or spermacide (when marketed within the country).
•II. intrauterine device (inserted at least 2 months prior to Screening visit); in addition, during study use of condom and/or spermacide (when marketed within country).
•NOTE: vasectomy of the partner is not considered sufficient contraception and one of the 2 methods listed above must be used.
•III. Condom (male or female) with spermacide (when marketed within the country).
•IV. diaphargm or cervical cap with spermacide (when marketed within the country) and condom (male).
•7. Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead ECG conduction intervals must be within gender specific normal range (e.g., QTcF males <= 450 msec, PR interval <= 220 msec females QTcF <= 450 msec, PR interval <= 200 msec). ECGs are to be judged by the investigator or subinvestigator as per standardized procedures.
•8. Subjects* clinical laboratory tests (CBC, blood chemistry, coagulation and urinalysis) must be within normal limits or clinically acceptable to the investigator and within an allowed expanded range supplied by sponsor (Appendix 2). However, subject*s liver function test results (e.g.., AST, ALT) must not be elevated above the normal limits at Screening and on Day -1. No rescreening of liver function tests will be allowed.
•9. Vital sign measurements must be within the following ranges: (Individuals with values outside of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.
•a. body temperature, between 35.5°C and 37.5°C
•b. systolic blood pressure, 90 to 150 mm Hg
•c. diastolic blood pressure, 40 to 100 mm Hg
•d. pulse rate, 50 to 100 bpm
•10. Non-vasectomized men must agree to use a condom with spermicide (when marketed in the country), double-barrier contraception, or abstain from sexual intercourse, during the trial and for 3 months after stopping the medication.
•11. Subjects must be free

排除标准

•1. Current diagnosis of psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia, current or recently treated depressive disorders, or Columbia-Suicide Severity Rating Scale (C-SSRS) indicative of suicidal ideation or behavior at screening.
•2. Past history of the anxiety disorder including panic attack, depression, obsessive compulsive disorder, phobias restricting normal daily function, social anxiety, and paranoia.
•3. History of alcohol abuse (more than an average of 2-drinks per day) within the past 2 years.
•4. History of smoking within the past year.
•5. Failure of the drug of abuse tests at screening or check-in.
•6. Positive for HIV, or Hepatitis B or C at screening.
•7. Blood donation or blood loss within 60 days of screening or plasma donation within 7 days of screening.
•8. Subjects with a history of bleeding disorders or coagulopathies.
•9. History of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary disease, sleep apnea or any other ventilatory / lung disease.
•10. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than four investigational drug studies within 1 year prior to screening.
•11. Inability to perform acceptable, quality spirometry, and FEV1 <80% of predicted for age, sex and height according to standard criteria, e.g., ATS, ECCS.
•12. History of drug abuse within 3 years.
•13. Subjects with excessive facial hair preventing sealing of the occlusive face mask for ventilatory monitoring.
•14). Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the sponsor prior to enrollment into the trial:
•a. history of pancreatic injury or pancreatitis;
•b. history or presence of liver disease or liver injury;
•c. history or presence of impaired renal function as indicated by clinically significant elevation in creatinine, BUN/urea, urinary albumin, or clinically significant urinary cellular constituents ; or
•d. history of urinary obstruction or difficulty in voiding.
•15. Subject who has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject*s ability to participate in the trial.
•16. Subjects who are part of the study staff personnel or family members of the study staff personnel.
•17. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial.
•18. Subjects who have a history of malignancy.
•19. Personal or family history of malignant hyperthermia.
•20. Personal or family history of arrhythmias or ECG conductance abnormalities.
•21. Subjects with a history of daily consumption of caffeine greater than 6 servings (40 mL each) from beverages (e.g., coffee, tea, soft drinks) and food stuffs (e.g., chocolate, ice cream, cookies) (45 gm each).
•22. Subjects who have used any drugs or substances known to inhibit (within 10 days) or induce (within 28 days) CYP450 enzymes prior to the first dose.
•23. Subjects who have received monoamine oxidase inhibitors within 28 days of starting the study.
•24. Subjects who are taking hormone replaceme

研究者

发起方

Galleon Pharmaceuticals, Inc

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