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

NCT07849153 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: FIH-AUS 110
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• Incidence of TEAEs

  From Day 1 to day 30 (EOT visit)

• Incidence of SAEs

  From Day 1 to day 30 (EOT visit)

• Number of participants with abnormal vital signs

  Days 1, 2,3,8,15 and day 30 (EOT visit)

• Number of participants with abnormal Physical examination findings

  From Day 1 to day 30 (EOT visit)

• Number of participants with abnormal ECG readings

  Days 1, 2 and Day 3

• Number of participants with abnormal Laboratory findings

  Days 1,3,8,15 and Day 30 (EOT visit)

Secondary Outcomes (4)

• Plasma PK parameters- Cmax (maximum serum concentration)

  Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)

• Plasma PK parameters- Tmax (time to maximum serum concentration)

  Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)

• Plasma PK parameters- AUC0-last (area under the concentration-time curve from zero to the last quantifiable concentration)

  Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)

• Plasma PK parameters- AUC0-inf (area under the concentration-time curve from zero to infinity)

  Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)

Study Arms (3)

Hadlima® Group 1

EXPERIMENTAL

Drug: Hadlima®

Hadlima® Group 2

ACTIVE COMPARATOR

Drug: Hadlima®

Hadlima® Group 3

ACTIVE COMPARATOR

Drug: Hadlima®

Interventions

Hadlima® DRUG

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

Hadlima® Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg
• Not pregnant or breastfeeding, or willing to cease breastfeeding.
• Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until 5 months after the last dose of IP.
• Males must agree to not donate sperm from the first dose of IP until at least 5 months after the last dose of IP.
• WOCBP must agree to not donate ova from the first dose of IP until at least 5 months after the last dose of IP.
• Nonsmoker. Participants who smoke ≤ 5 cigarettes or equivalent (e.g., cigars, vaping, nicotine patches) per week may be included in the study at the discretion of the Investigator or designee if they agree to abstain for 72 hours before dosing through discharge from inpatient period.

You may not qualify if:

• History of chronic inflammatory or autoimmune disease requiring immunosuppressive therapy.
• History or presence of any clinically significant medical condition, including:
• Dysphagia, achalasia, or swallowing disorders, including difficulty in swallowing oral medication.
• Zenker's diverticulum.
• Severe motility disorders such as gastroparesis (delayed gastric emptying) or slow intestinal transit including but not limited to significant gastroesophageal reflux disease, or irritable bowel syndrome under care of a physician.
• Gastrointestinal (GI) diverticular disease.
• Gastric, small bowel, and/or colonic resections, strictures, and/or obstructions.
• History of inflammatory bowel disease including Crohn's disease or ulcerative colitis.
• Gastrointestinal surgery (e.g., gastrectomy, laparoscopic banding, Roux-en-Y).
• Radiation or chemotherapy-induced enteritis.
• Abdominal or pelvic surgery that could impair GI transit per the opinion of the Investigator (history of appendectomy or cholecystectomy are permitted).
• Symptomatic hiatal hernia.
• Known history of bezoars.
• Recent history of peptic ulcer disease within 6 months.
• History of cardiovascular, hepatic, renal, pulmonary, GI, neurologic, hematologic, endocrine, psychiatric, or autoimmune disease.

Sponsors & Collaborators

• Biora Therapeutics, Inc.: lead

Study Officials

• James Connell, Dr.

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09