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NOT YET RECRUITING
NCT07849153
PHASE1

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

Sponsor: Biora Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Hadlima®

Route of administration: via BioJet™ device oral capsule Dose: 30 mg

DRUG

Hadlima®

Route of administration: by SC injection Dose: 20 mg

DRUG

Hadlima®

Route of administration: by SC injection Dose: 40 mg