A study assessing immunogenecity of QL0605 and US Neulasta®.

• Research type

  Research Study

• Full title

  A randomized, double-blind, 2 period parallel-arm study to assess the immunogenicity of 2 subcutaneous doses of QL0605 (6 mg) compared to 2 subcutaneous doses of US Neulasta® (6 mg) in healthy male and female subjects.

• IRAS ID

  286956

• Contact name

  Oyeniyi Diya

• Contact email

  Oyeniyi.Diya@PAREXEL.com

• Sponsor organisation

  Qilu Pharmaceutical Co., Ltd.

• Eudract number

  2019-002458-21

• Duration of Study in the UK

  1 years, 2 months, 14 days

• Research summary

  This is a Phase I, multi centre, randomised, double blinded, 2 period parallel arm trial in 300 healthy male and female participants.

  The purpose of this trial is to investigate the immunogenicity (ability to cause an immune response in the body) of QL0605 compared to a reference product called US Neulasta®, when applied under the skin by injection (subcutaneous administration), in both male and female healthy participants. Pegfilgrastim, the active ingredient of QL0605 and US Neulasta®, causes the production of anti drug antibodies (ADA) and neutralising ADA (which switches off the antibodies). The amounts produced will be measured to determine the similarity of the two products. The trial will also investigate the possible safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects that the ADA produced may have. PK refers to how the drug is taken up into and distrubuted throughout the body; broken down and finally removed from the body, whereas PD refers to the effect of the drug on the body and how it works to bring about this effect.

  The participants will be randomised (randomly determined, like flipping a coin) into 2 groups of 150 participants each. In each group one of the two drugs will be administered twice (distributed over 2 treatment periods at least 6 weeks apart):

  Groups Period 1 Period 2

  Group 1
  (150 participants) QL0605 QL0605

  Group 2
  (150 participants) US-Neulasta® US-Neulasta®

  The total trial duration for each participant will be approximately 17 weeks. The trial includes a screening period of up to 4 weeks before randomisation (Day 1), a stay at the clinic for 6 days after each injection, and a 7 week post-treatment period after the last injection.

  Since there is a high degree of similarity of QL0605 with both US and EU approved Neulasta, it is expected that QL0605 will be safe for use in humans.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  20/SC/0289

• Date of REC Opinion

  14 Sep 2020

• REC opinion

  Further Information Favourable Opinion