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

A Phase 1, Single-Center, Open-label, Infusion Dose Optimization Study of ABP-700 in Healthy, Adult Subjects - ANVN-01-04 (CS0245)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42498

Enrollment

Registered

2015-06-17

Start date

2015-08-03

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: 1. 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 will be monitored through AEs, physical examination, safety laboratory tests (serum chemistry, hematology, arterial blood gas, urinalysis, and coagulation), serum methanol concentration (for subjects receiving a total dose of ABP-700 that is above what has already been tested in clinical studies), vital signs (blood pressure [including mean arterial pressure], heart rate, RR, SpO2 and body temperature), ECGs (12-lead continuous Holter, 3-lead telemetry and 12-lead ECGs at screening, check-in, 12 hours post-dose and follow-up), infusion site reaction monitoring, and respiratory function (respiratory pattern and occurrence of apnea).	—

Measure

Time frame

Safety will be monitored through AEs, physical examination, safety laboratory tests (serum chemistry, hematology, arterial blood gas, urinalysis, and coagulation), serum methanol concentration (for subjects receiving a total dose of ABP-700 that is above what has already been tested in clinical studies), vital signs (blood pressure [including mean arterial pressure], heart rate, RR, SpO2 and body temperature), ECGs (12-lead continuous Holter, 3-lead telemetry and 12-lead ECGs at screening, check-in, 12 hours post-dose and follow-up), infusion site reaction monitoring, and respiratory function (respiratory pattern and occurrence of apnea).

—

Secondary

Measure	Time frame
The PK properties of ABP-700 will be evaluated by assessing the following PK parameters from plasma concentrations from venous and arterial samples: Cmax, AUC0-t, AUC0-inf, tmax, tlast, kel, t1*2, CL, Vz (from venous samples only). The PK of the metabolite (CPM-acid) will also be computed when possible from venous and arterial samples. Dose-proportionality will be evaluated using the power model. The PD profile of ABP-700 and the pre-treatment will be evaluated using the following markers: - 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. The following ECG parameters will be provided (extracted from 12-lead Holter ECG) for all timepoints: RR, PR, QRS, QT, QTcF, QTcI, Heart Rate, T- and U- wave morphology classifications.	—

Measure

Time frame

The PK properties of ABP-700 will be evaluated by assessing the following PK parameters from plasma concentrations from venous and arterial samples: Cmax, AUC0-t, AUC0-inf, tmax, tlast, kel, t1*2, CL, Vz (from venous samples only). The PK of the metabolite (CPM-acid) will also be computed when possible from venous and arterial samples. Dose-proportionality will be evaluated using the power model. The PD profile of ABP-700 and the pre-treatment will be evaluated using the following markers: - 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. The following ECG parameters will be provided (extracted from 12-lead Holter ECG) for all timepoints: RR, PR, QRS, QT, QTcF, QTcI, Heart Rate, T- and U- wave morphology classifications.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)