Single centre, randomised, open-label, 2-dose, parallel trial to compare immunogenicity, safety, tolerability, and pharmacodynamics of MYL-1401H and US-licensed Pegfilgastrim (NEULASTA®) after two subcutaneous (SC) injections at one dose level (6 MG) in healthy subjects.

Neulasta® is a drug registered for treatment of a shortage of white blood cells
in order to prevent infections. It is used mostly for cancer patients to treat
the side effects of chemotherapy. Neulasta® is the brand name; the active
ingredient is called pegfilgrastim. This is a protein which is very similar to
the human version *granulocyte colony stimulating factor* (also known as GCSF
or filgrastim). GCSF is present in the human body by nature. Therefore,
Neulasta® is called a *biological*. The difference between naturally occurring
GCSF and Neulasta® (pegfilgrastim) is the attachment of a large chain of
molecules (a polymer) to pegfilgrastim. This makes the protein stay longer in
the body so patients need to receive drug less often to achieve the same
effect. MYL-1401H is a new pegfilgrastim strongly resembling Neulasta®. Both
Neulasta® and MYL-1401H are produced with the help of bacteria which have
received a human gene which makes them able to produce this protein. MYL-1401H
is not registered as a drug but has been given to humans before. In this study
the volunteers will receive MYL-1401H or Neulasta® US (United States licensed
product) on two separate occasions.

The purpose of the study is to investigate the ability of MYL-1401H to evoke an
immune response (immunogenicity) as compared to Neulasta® US. In addition, the
effect of MYL-1401H on blood cells as compared to Neulasta® US will be
investigated. The study further investigates how quickly and to what extent
MYL-1401H is absorbed and eliminated from the body (this is called
pharmacokinetics) as compared to Neulasta® US. Furthermore, it will be
investigated to what extent MYL-1401H is tolerated.

For the purpose of the study the concentration of pegfilgrastim, the amounts of
certain types of white blood cells and the possible development of antibodies
against pegfilgrastim in the volunteers blood will be investigated.

The actual study will consist of 2 periods during which the volunteers will
stay in the clinical research center in Zuidlaren for 4 days (3 nights). Each
period is followed by 3 ambulant visits during which they will visit the
clinical research center in Zuidlaren. The time interval between the different
periods (time between two administrations of study compound) is 4 weeks.

In each period, Day 1 is the day of administration of study compound. The
volunteers are expected at the clinical research center at 14:00 h in the
afternoon prior to the day of administration of study compound. They will be
required not to have consumed any food or drinks during the 4 hours prior to
arrival in the clinical research center (with the exception of water).They will
leave the clinical research center on Day 3 and the volunteers
will return for the ambulant visits on Days 7, 15 and 22. For the ambulant
visits they are expected at the clinical research center in Zuidlaren.

Each period a dosage of 0.6 mL MYL-1401H or Neulasta® US by subcutane (SC)
injection.

During the investigation, various assessements will be done that can be
experienced as more or less stressfull.
Blood draw, SC injections and the ECG can be experienced as stressfull in this
respect.