Safety and Immunogenicity of MSB11455 in Healthy Participants
NCT ID: NCT03251339
Last Updated: 2019-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
336 participants
INTERVENTIONAL
2017-08-21
2018-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with laboratory test results within predefined ranges.
Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Fresenius Kabi SwissBioSim GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Radmila Kanceva, MD, PhD
Role: STUDY_DIRECTOR
Fresenius Kabi SwissBioSim
Locations
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Auckland Clinical Studies Ltd
Auckland, , New Zealand
Christchurch Clinical Studies Trust
Christchurch, , New Zealand
Countries
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Other Identifiers
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EMR200621-003
Identifier Type: -
Identifier Source: org_study_id
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