A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects (NCT05325346) | Clinical Trial Compass
CompletedPhase 1
A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects
United States12 participantsStarted 2022-03-07
Plain-language summary
The study is designed to characterize the safety and tolerability of VLX-1005 and argatroban administered intravenously, either alone or in combination; and the pharmacokinetics and pharmacodynamics and potential interaction of both agents in a population of healthy subjects.
Who can participate
Age range19 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive.
✓. Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
✓. hysteroscopic sterilization
✓. bilateral tubal ligation or bilateral salpingectomy
✓. hysterectomy
✓. bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
✓. Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities at screening, and/or before administration of the initial dose of study drug.
✓. Body weight ≥ 50 kg at the screening visit.
Exclusion criteria
✕. Blood donation or recipient of blood transfusion in previous 12 weeks.
✕. History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatobiliary, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
✕. History of neoplastic disease (with the exception of adequately treated nonmelanomatous skin carcinoma).
. Mentally or legally incapacitated (e.g. has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years).
✕. Fever (body temperature \>38 C) or symptomatic viral/bacterial infection or use of antibiotics within 2 weeks prior to Screening.
✕. Supine resting blood pressure (BP) \>140/90 mmHg or heart rate (HR) \>100 beats per minute at Screening and at Day -2.
✕. Clinically significant abnormality on ECG performed at the Screening Visit or prior to administration of the initial dose of study drug. (Abnormalities include not being in sinus rhythm, IVCD/BBB or QTcF\>450 ms for males (470 ms for females)).
✕. Out of range (on repeat) testing for coagulation tests.