A Phase 1, Single-Center, Open-Label, Dose Optimization Study of ABP-700 in Healthy, Adult Subjects

A Phase 1, Single-Center, Open-Label, Dose Optimization Study of ABP-700 in Healthy, Adult Subjects - ANVN-03 (CS0240)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42641

Enrollment

100

Registered

2015-04-16

Start date

2015-04-22

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anesthesia Not applicable

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG,vital signs). Furthermore a blood a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy, adult, men and women, 18-55 years of age, inclusive

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of ABP-700 will be assessed through AEs, physical examination, safety laboratory tests (serum chemistry, hematology, urinalysis, and coagulation), vital signs (blood pressure, heart rate, RR, SpO2 and body temperature), ECGs (12-lead ECG and 3-lead ECG), infusion site reaction monitoring, myoclonic activity, and respiratory function (respiratory pattern and occurrence of apnea).	—

Measure

Time frame

Safety and tolerability of ABP-700 will be assessed through AEs, physical examination, safety laboratory tests (serum chemistry, hematology, urinalysis, and coagulation), vital signs (blood pressure, heart rate, RR, SpO2 and body temperature), ECGs (12-lead ECG and 3-lead ECG), infusion site reaction monitoring, myoclonic activity, and respiratory function (respiratory pattern and occurrence of apnea).

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Secondary

Measure	Time frame
The PK properties of ABP-700 will be evaluated by assessing the following PK parameters from plasma concentrations from venous samples: Cmax, AUC0-t, AUC0-inf, tmax, tlast, kel, t1*2, CL, Vz, and additional parameters for multiple dose PK, if applicable, such as Cavg and AUC0-tau.. Dose-proportionality will be evaluated using the power model. 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. The markers will be evaluated by means of: • MOAA/S scores [ranging from 0 (does not respond to painful trapezius squeeze) to 5 (responds readily to name spoken in normal tone). • BIS scores [ranging from 0 100]. • Clinical signs	—

Measure

Time frame

The PK properties of ABP-700 will be evaluated by assessing the following PK parameters from plasma concentrations from venous samples: Cmax, AUC0-t, AUC0-inf, tmax, tlast, kel, t1*2, CL, Vz, and additional parameters for multiple dose PK, if applicable, such as Cavg and AUC0-tau.. Dose-proportionality will be evaluated using the power model. 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. The markers will be evaluated by means of: • MOAA/S scores [ranging from 0 (does not respond to painful trapezius squeeze) to 5 (responds readily to name spoken in normal tone). • BIS scores [ranging from 0 100]. • Clinical signs

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)