A Single-Center, Open-label, Single-Arm Study to Evaluate the Effects of Repeat Doses of Subcutaneously Delivered Sumatriptan Via the Intraject System of Local Injection Site Signs in Healthy Adult Subjects.

ZX001-0703

Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.

2007-12-01

2007-12-01

2007-12-01

Completed

Early phase I

18

Inclusion Criteria: * Female subjects of child-bearing potential must agree to use acceptable birth control * Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection * Fluent in the spoken and written English language * Provide written informed consent to participate in the study and be willing to comply with the study procedures * Non-tobacco user for at least 12 months prior to screening (all types of tobacco, including cigars) Exclusion Criteria: * A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease * Other significant underlying cardiovascular diseases including uncontrolled hypertension * Hemiplegic or basilar migraine * A history or diagnosis of severe hepatic or renal impairment * A history of epilepsy or seizure or other serious neurologic condition * A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs * A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications * Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation * Pregnancy or breast-feeding * Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2023-05-09