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The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSB11455 | Experimental | 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. |
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| US-Neulasta | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSB11455 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Immunogenicity of MSB11455 Compared to Neulasta | Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB) | From first dose up to end of study (Up to 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs) | Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs | Day 1 up to a maximum of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radmila Kanceva, MD, PhD | Fresenius Kabi SwissBioSim | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies Ltd | Auckland | 1150 | New Zealand | |||
| Christchurch Clinical Studies Trust |
| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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| US-Neulasta | Drug | 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. |
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| Christchurch |
| 8001 |
| New Zealand |