Trials / Completed
CompletedNCT02675023
Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
A Randomized, Open-label, Two-arm, Parallel Group, Single Dose Study to Assess the Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 603 (actual)
- Sponsor
- Momenta Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | M923 | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2016-02-05
- Last updated
- 2019-10-15
Locations
2 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT02675023. Inclusion in this directory is not an endorsement.