This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.
After successful screening, each subjects will be randomly allocated to one of the following six possible sequences, according a 1:1:1:1:1:1 randomization scheme: Sequence\_1: Treatment A -\> Treatment B -\> Treatment C ; Sequence\_2: Treatment A -\> Treatment C -\> Treatment B ; Sequence\_3: Treatment B -\> Treatment A -\> Treatment C ; Sequence\_4: Treatment B -\> Treatment C -\> Treatment A ; Sequence\_5: Treatment C -\> Treatment A -\> Treatment B ; Sequence\_6: Treatment C -\> Treatment B -\> Treatment A ; In study Period 1, Subjects will be administered MYL-1401H (Treatment A), EU-Neulasta(Treatment B) or US-Neulasta (Treatment C). After the 1st crossover, subjects will enter Study period 2 and will receive one of the remaining alternate treatments. After the 2nd crossover, subjects will enter Study period 3 and will receive the other alternate treatment. The washout between drug administrations is at least 4 weeks. Final follow-up visit is scheduled 4 weeks after the last study drug administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
218
PRA Health Sciences - Early Development Services
Zuidlaren, Netherlands
Pharmacodynamics: Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]
Time frame: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), and on Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29
Pharmacodynamics: Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax
Time frame: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29
Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim
Pharmacokinetics as measured by total AUC after extrapolation from time t to time infinity
Time frame: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29
Maximum Serum Concentration (Cmax) of pegfilgrastim
Pharmacokinetics as measured by peak serum concentration of Pegfilgrastim
Time frame: Day 1 (0.5, 1, 2, 4, 6, 8, 10, 12, 20 h), Days 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29
Frequency of Adverse Events
Safety as measured by incidence of Adverse Events
Time frame: Daily until Day 9, then on Day 12, 15, 22 of each study period, and at follow-up visit (day 84).
Safety Variable - Tolerability as measured by Injection Site reactions
Tolerability as measured by Injection Site reactions
Time frame: Daily until Day 5 of each period
Safety Variable - Immunogenicity as measured by presence of Anti Drug Antibodies
Immunogenicity as measured by presence of Anti Drug Antibodies
Time frame: Day 1 each period and at follow-up (Day 84)
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