Trials / Terminated
TerminatedNCT05813314
Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants
A Phase 1, Randomized, Open-Label, Sponsor-Open, Two-Sequence, Two-Period Crossover Study to Investigate the Bioequivalence of a Single Subcutaneous Dose of BMN 111 Administered Using Either a Vial and Syringe or Injector Pen in Healthy Adult Participants
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- BioMarin Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to establish the bioequivalence of a single SC dose of BMN 111 administered using a vial and syringe versus using an injector pen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | BMN 111 administration via Injector Pen | BMN 111 Injection will be given using an injector pen |
| DRUG | BMN 111 administration via vial and syringe | BMN 111 Injection will be given using vial and syringe |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2023-06-14
- Completion
- 2023-06-14
- First posted
- 2023-04-14
- Last updated
- 2023-10-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05813314. Inclusion in this directory is not an endorsement.