A Phase 1, Single-Center, Single-Blind, Placebo and Propofol Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous (IV) Infusion Doses of ABP-700

The research medication is an IV anesthetic drug being developed for monitored
anesthesia care (MAC) and/or general
anesthesia in patients undergoing diagnostic or therapeutic procedures.

Primary objectives:
- to assess the safety and tolerability of a single ascending intravenous (IV)
infusion doses of the research medication.
- to determine the maximum tolerated dose (MTD) of IV infusion doses of the
research medication.

Secundary objectives:
- to characterize the pk of the research medication and it's primary metabolite
- to assess the pd of the research medication
- to investigate the dose-resonse and pk/pd relationships.

This study will be a single-blind, randomized, placebo and active controlled,
single ascending dose study. There are 7 cohorts, consisting of 8 subjects
within each cohort. Out of 8 subjects, 5 will receive research medication, 2
will receive propofol and 1 will receive a placebo. Pre-medication (medication
prior to dosing of the study drug) will be administered in at least 2 cohorts.
In at least one cohort there will be a bolus administered before the infusion
dose.

In the 8th and 9th (potential expansion cohort of 8) cohort, 4 subjects will
receive research medication without pre-medication followed by 4 subjects with
premedication.

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
and urine sample will be taken for
laboratory tests and an alcohol breath test and drug screen will be done.

During the stay in the clinic the subject will receive the research medication
once on Day 1. Safety will be monitored and
sedation/anesthesia will be assessed throughout thestudy. Arterial and venous
serial blood samples will be collected. The
subjects will be asked for possible side effects onregular basis.

Finally, a follow-up visit will take place.

The dose levels for this study have been selected on the basis of research
results in animals and healthy volunteers.

The study drug has previously been tested in 50 humans and was generally well
tolerated. A number of side-effects, possibly linked to use of the test
medication, were reported. musclesThe most common adverse events (occurring in
>5% of ABP-700 treated subjects) include muscle twitching, apnea,
hyperventilation, tachycardia, restlessness, increased blood pressure, hiccups,
abnormal respiration, decreased oxygen saturation and emergence delirium which
are all consistent with the mechanism of action observed with this type of
medication.

If you are assigned to a group receiving pre-treatment with fentanyl the most
commonly experienced side effects include: respiratory depression (too shallow
or slow breathing, shortness of breath, short periods of not breathing),
skeletal and chest muscle rigidity and
slow heart rate.

All drugs have a potential risk of causing an allergic reaction, which if not
treated promptly, could become life threatening. The subjects will be monitored
for any allergic reactions and emergency treatment will be provided as needed.

The blood collection procedure is not dangerous, but may cause discomfort or
bruising.
Occasionally, fainting or an infection at the bloodsampling site can occur.

Shaving may be required for proper placement of ECG patches. This may cause
irritation or bleeding of the skin.

ECG patches may cause redness, itching, rash or blisters on the skin and/or
hair loss due to removal of ECG patches.