A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 336
- Locations
- 2
- Primary Endpoint
- To Assess the Immunogenicity of MSB11455 Compared to Neulasta
Study Overview
Brief Summary
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who provide signed and dated written informed consent.
- •Participants with laboratory test results within predefined ranges.
- •Other protocol defined inclusion criteria could apply.
Exclusion Criteria
- •Participants with known hypersensitivity to any component of US-Neulasta or MSB
- •Other protocol defined exclusion criteria could apply.
Arms & Interventions
MSB11455
Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.
Intervention: MSB11455 (Drug)
US-Neulasta
Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
Intervention: US-Neulasta (Drug)
Outcomes
Primary Outcomes
To Assess the Immunogenicity of MSB11455 Compared to Neulasta
Time Frame: From first dose up to end of study (Up to 3 months)
Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)
Secondary Outcomes
- Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)(Day 1 up to a maximum of 1 year)