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An Early Feasibility Study of the BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy Participants
Sponsor: Biora Therapeutics, Inc.
Summary
This study is testing the BioJet™ oral device, a capsule-based method of delivering medicine by mouth, in healthy adult volunteers. Participants will be randomly assigned to one of three groups and will receive a single dose of the study treatment. The purpose of the study is to compare Hadlima® given through the BioJet™ device with Hadlima® given by a SC injection under the skin. Researchers will evaluate how safe and well tolerated the treatments are, how the body processes the medicine, and whether the body's immune system responds to it. Approximately 30 healthy adults will take part in this study.
Official title: A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Early Feasibility of BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10-20
Completion Date
2027-02-15
Last Updated
2026-09-30
Healthy Volunteers
Yes
Conditions
Interventions
Hadlima®
Route of administration: via BioJet™ device oral capsule Dose: 30 mg
Hadlima®
Route of administration: by SC injection Dose: 20 mg
Hadlima®
Route of administration: by SC injection Dose: 40 mg