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Safety and Immunogenicity of MSB11455 in Healthy Participants

NCT03251339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2019-07-02

No results posted yet for this study

Summary

The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Principal Investigators

  • Radmila Kanceva, MD, PhD · Fresenius Kabi SwissBioSim

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-02-05
Completion
2018-09-22
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03251339 on ClinicalTrials.gov