A Phase 1, Single-Center, Double-Blind, Placebo Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ABP-700 after a Single Ascending Bolus Dose
- Conditions
- Preliminary safety study, first in human
- Registration Number
- NL-OMON27439
- Lead Sponsor
- Annovation Biopharma(University Medical Center Groningen)
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1.Healthy, adult, men and women, 18-45 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 1. Safety and Tolerability as assessed through: AEs, physical examination, safety laboratory tests (serum chemistry, hematology, arterial blood gas, urinalysis, and coagulation), vital signs (blood pressure [including mean arterial 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). Timepoints: Day 1, 2 and 5. <br /> 2. Evaluation of cortisol levels before dosing and after synthetic ACTH administration will be evaluated to assess the effect of ABP-700 on adrenal function. Timepoints: Day 1
- Secondary Outcome Measures
Name Time Method 1. PK properties of ABP-700 will be evaluated by assessing PK parameters from plasma concentrations from venous and arterial samples<br /><br>2. The PD profile of ABP-700 will be evaluated using onset of sedation/anesthesia, level of sedation/anesthesia over time, emergence from sedation/anesthesia, and duration of sedation/anesthesia as markers.