DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES AND THE EFFECT OF FOOD ON ORAL WCK 4873 IN HEALTHY ADULT VOLUNTEERS

WCK 4873 is a new investigational compound that may eventually be used for the
treatment of bacterial respiratory tract infections. A respiratory tract
infection is an infection of the mucous membrane of the respiratory tract
(nose, throat, airways and lungs). In the air you breathe, many pathogens such
as viruses and bacteria are present. Once a virus or bacteria settles in the
mucous membrane of the respiratory tract it will result in an infection. The
most common symptoms of respiratory tract infections are: coughing, sore
throat, hoarseness, runny nose, headache and fever.

To determine the safety and tolerability of single ascending doses of oral WCK
4873 in healthy subjects.
To evaluate the pharmacokinetic (PK) profile of single ascending doses of oral
WCK 4873 in healthy subjects.
To evaluate the effects of food on the tolerability and PK profile at selected
doses of WCK 4873 in healthy subjects.

A phase 1, randomized, double-blind, single center prospective,
placebo-controlled, sequential cohort study in 78 healthy male and female
subjects.

Cohorts 1 and 2 will receive a single dose of WCK 4873 or matching placebo
under fasting conditions on Day 1.
Subjects in Cohorts 3 and 4 will receive a single oral dose of WCK 4873 in a 2
way crossover design, i.e., in one period under fasting conditions and in the
other period under fed conditions.
Cohorts 5, 6 and the optional Cohort 7 will receive a single oral dose of WCK
4873 or matching placebo under fasting or fed condition.

Screening and follow-up:
During screening and follow-up clinical laboratory, full physical examination,
ECG; at eligibility screening will be performed amongst others: medical
history, urine tests and drug screen, HBsAg, anti-HBc, anti HCV, anti-HIV 1/2

Observation period:
Cohort 1, 2, 5, 6, 7 (Cohort 7 is optional): one period in clinic from -18 h up
to 72 h after start of drug administration
Cohort 3, 4: two periods in clinic from -18 h up to 72 h after start of drug
administration

Assesments during the study conduct:
On pre-defined timepoints blood will be collected for measuring the PK of WCK
4873 and PMN.
There will also be collected blood for measuring protein binding of WCK 4873 on
pre-defined timepoints
Besides to blood, urine and feces will be collected to measure PK and the
metabolites of WCK 4873

Safety will be assessed during the study by means of clinical laboratory,
physical examination, ECGs and measuring LFTs on pre-defined timepoints.

Single dose of WCK 4873 in the form of tablets up to a maximum of 1200 mg

Procedures: pain, light bleeding, heamatoma, possibly an infection.