Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Thrombosis

In brief

The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.

Key facts

Study ID

NCT03453060

Run by

Aronora, Inc.

People needed

21

Starts

2018-05-30

Expected to finish

2018-11-25

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, adult, male and/or female (females of non-childbearing potential only), 18 to 55 years of age, inclusive, at screening.
• Continuous non-smoker, who has not used nicotine-containing products for at least 3 months prior to dosing, based on subject self-reporting.
• Body mass index (BMI) ≥ 18 and < 29 (kg/m2) at screening and weight between 50 and 125 kg (inclusive) at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms, as deemed by the PI or designee.
• A female must be of non childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to dosing:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy. or be postmenopausal with amenorrhea for at least 1 year prior to dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing of study drug. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non vasectomized male).
• If male, must agree to not donate sperm from dosing until 90 days after dosing.
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if…

• Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to dosing.
• Consumes 3 units or more of alcohol per day (e.g., 1 unit is equivalent to 240 mL of wine, 1 bottle of beer [12 oz.], or 1 shot of liquor [1 oz.]).
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug and excipients or related compounds.
• History or presence of a disease or disorder, acquired or inherited, that is active, or could be reasonably expected to become active during the study, including but not limited to:
• Hypersensitivity to ß-lactam / penicillin derivatives;
• Bleeding and blood coagulation disorders, including stroke, hemophilias, thrombophilias, or heparin-induced thrombocytopenia;
• Ischemic disorders, including stroke, heart attack, coronary artery disease;
• Gastrointestinal disorders, including gastrointestinal bleeds, gallstones, ulcers, diseases or dysfunction of the liver and excluding appendectomy and/or cholecystectomy;
• Genitourinary disorders, including renal disease;
• Cardiovascular disorders, including aneurysms, vasculitis;
• All conditions that are associated with taking medications for pain;
• Infection of any organ or system within 30 days of dosing;
• Malignant and cancerous neoplasms of any organ or system;
• Psychiatric and behavioral disorders;
• A clinically significant hematological disorder of any type;
• Inflammation and inflammatory diseases of any organ system.
• Females of childbearing potential.
• Females who are pregnant or who are lactating.
• Positive urine drug or alcohol results at screening or check in.
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• Supine blood pressure is less than 90/50 mmHg or greater than 140/90 mmHg at screening.
• Supine heart rate is lower than 40 bpm or higher than 99 bpm at screening.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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