drugset
drugset / Trial / NCT07849153

An Early Feasibility Study of the BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy Participants

NCT07849153 ↗

Phase 1 Not yet recruiting 30 enrolled Biora Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-10-20
Primary completion
2027-01-15
Completion
2027-02-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 20 mg Oral
Comparator Adalimumab Monoclonal antibody 30 mg Oral
Comparator Adalimumab Monoclonal antibody 40 mg Oral

Indications

No indication recorded.