An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects

UCB4940 is a new investigational compound that may eventually be used for the
treatment of, autoimmune diseases like Rheumatoid Arthritis and psoriasis.
These diseases cause the immune system to attack parts of the body. UCB4940 is
a protein (a monoclonal antibody) that binds to a protein that is involved in
inflammation reaction (interleukin [IL] 17A and 17F). Binding limits the immune
reaction of the body. UCB4940 is not registered as a drug but has been given to
humans before.

The purpose of the study is to investigate how quickly and to what extent an
injection under the skin (subcutaneous [sc]) of UCB4940 is absorbed and
eliminated from the body (this is called pharmacokinetics) in comparison with
the absorption and elimination when administered as an infusion in a vein
(intravenous [iv]), (this is called absolute bioavailability). In addition the
safety and tolerability of UCB4940 sc and iv, and the possible presence of
proteins your body develops against UCB4940 (anti-UCB4940 antibodies) will be
studied

The actual study will consist of 1 period during which the volunteer will stay
in the clinical research center in Zuidlaren for 4 days (3 nights) followed by
11 appointments in the following 20 weeks, during which the volunteer will
visit the clinical research center in Zuidlaren (ambulatory visits).

During the study the volunteer will receive UCB4940 as a sc injection of 1 or 2
mL or as an iv infusion of 20 ml (2 mL UCB4940, diluted to 20 mL infusion
solution). The iv infusion will last 1 hour.

The study will consist of 1 period during which the volunteer will receive
UCB4940 once. UCB4940 will be given in the form of a sc injection or an iv
infusion.

Please refer to the table below to see the planned dose levels for the groups.
Whether the volunteer will receive UCB4940 as an sc injection of 80 or 160 mg,
or an iv infusion of 160 mg will be determined by chance. Should, in the
opinion of the investigators, unacceptable adverse effects appear, the study
will be discontinued.

The planning of the study is as follows:

Treatment Duration Volume How often Day
UCB4940 80 mg sc - 1 mL Once 1
UCB4940 160 mg sc - 2 mL Once 1
UCB4940 160 mg iv 1 hour 20 mL Once 1

All potential drugs cause adverse events; the extent to which this occurs
differs. UCB4940 has been studied in one clinical study in patient with
psoriasis The most frequently observed adverse effects in this study were:
headache, throat pain, and common cold (nasopharingitis). Other adverse effects
observed were: stomach distension, stomach pain, vomiting, blood in stools, ear
infection, injection site reactions, dizziness, and fatigue. Based on the mode
of action of UCB4940 a decrease of certain blood cells (neutropenia), and
fungal or other infection could occur. The volunteer should be aware that the
aforementioned adverse effects and possibly other, still unknown adverse
effects, may occur during the study. However, with the doses used in this study
no serious adverse effects are expected.

Procedures: pain, minor bleeding, bruising, possible infection