Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Biora Therapeutics, Inc.Updated: Sep 30, 2026
Eligibility criteria

Body mass index between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg [+5]

History of chronic inflammatory or autoimmune disease requiring immunosuppressiv... [+21]