MedTrace Logo

Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants

NCT05813314 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-10-12

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2023-06-14
Completion
2023-06-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05813314 on ClinicalTrials.gov