A Phase 1, Single-Center, Open-label, Infusion Dose Optimization Study of ABP-700 in Healthy, Adult Subjects
- Conditions
- Monitored anesthesia care (MAC) and/or general anesthesia.
- Registration Number
- NL-OMON26835
- Lead Sponsor
- The Medicines Company, University Medical Center Groningen (UMCG)
- Brief Summary
none.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1.Healthy, adult, men and women, 18-55 years of age, inclusive.
2.Subject must give written informed consent before initiation of any study-related procedures.
Exclusion Criteria
1.History or presence of significant cardiovascular disease, or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome).
2.History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological (inclusive of any seizure disorder), or psychiatric disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of intravenous (IV) infusion doses and infusion dosing methodologies of ABP-700 alone or in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.
- Secondary Outcome Measures
Name Time Method To determine optimal intravenous infusion schema (dose and method(s)) of ABP-700 alone or in the presence of pre-medications to induce and maintain anesthesia.