A Phase 1, Single-Center, Open-Label, Dose Optimization Study of ABP-700 in Healthy, Adult Subjects
Recruiting
- Conditions
- Preliminary safety study
- Registration Number
- NL-OMON25663
- Lead Sponsor
- Annovation Biopharma, a wholly owned subsidiary of The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1.Healthy, adult, men and women, 18-55 years of age, inclusive.
2.Continuous non-smoker who has not used nicotine-containing products for at least 6 months prior to the first dose.
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 Safety and Tolerability as assessed through: AEs, physical examination, safety laboratory tests (serum chemistry, hematology, urinalysis, and coagulation), vital signs (blood pressure, heart rate, and body temperature), ECGs (12-lead ECG and 3-lead ECG), infusion site reaction monitoring, and respiratory function (respiratory pattern and occurrence of apnea).<br /><br>Pharmacodynamic driven dose optimization as assessed by MOAA/S and BIS.
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics (PK) of ABP-700.<br /><br>To assess the pharmacodynamics (PD) of ABP-700.<br /><br>To investigate dose response and PK/PD relationships<br>