A randomized double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety and pharmacokinetics of OCR 002 in healthy volunteers.

The drug to be given (OCR-002) is a new, investigational compound that may
eventually be used for the treatment of acute liver failure.
Due to liver failure, certain waste products are not removed from the body. One
of these is ammonia. The amount of ammonia that remains in the body disturbs
the normal function of the brain and may ultimately lead to death. OCR-002 is
meant to reduce the amount of ammonia in the body through another mechanism,
that not depends on the liver.

SAD
To evaluate the safety and tolerability of ascending single doses (SAD) of OCR
002 administered as intravenous (IV) infusions in healthy volunteers
To evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and
glutamine after a single IV infusion
To evaluate the urine PK of Phenylacetylglutamine (PAGN) after a single IV
infusion
MAD
to evaluate the safety and tolerability of multiple ascending single doses of
OCR-002 administered as IV infusions in healthy volunteers
to evaluate the plasma PK of phenylacetate and ornithine and glutamine after
multiple IV infusions
To evaluate the urine PK of PAGN after multiple IV infusions

SAD
a randomized, double-blind, placebo-controlled, single-ascending dose study
with two alternating cohorts and 3 cohorts (non-alternating) of six healthy
male and/or healthy female subjects each ;
MAD
a randomized, double-blind, placebo-controlled, multiple-ascending dose study
with six cohorts of six healthy male and/or healthy female subjects each
receiving an iv infusion of OCR-002 or placebo (five verum and one placebo) for
five days

Active substance OCR-0002 or placebo

Procedures: pain, light bleeding, aematoma, possibly an infection
Medication : increased or decreased heart rate, extra heart beats, nausea,
decreased appetite and somnolence