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

ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiora Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

History of chronic inflammatory or autoimmune disease requiring immunosuppressive therapy.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hadlima®

    Drug

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

  • Hadlima®

    Drug

    Route of administration: by SC injection Dose: 20 mg

  • Hadlima®

    Drug

    Route of administration: by SC injection Dose: 40 mg

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Hadlima® Group 1Experimental treatment 1 intervention
Group B: Hadlima® Group 2Active comparator 1 intervention
Group C: Hadlima® Group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of TEAEs

Time frame
From Day 1 to day 30 (EOT visit)
2

Incidence of SAEs

Time frame
From Day 1 to day 30 (EOT visit)
3

Number of participants with abnormal vital signs

Time frame
Days 1, 2,3,8,15 and day 30 (EOT visit)
4

Number of participants with abnormal Physical examination findings

Time frame
From Day 1 to day 30 (EOT visit)

Secondary outcomes

1

Plasma PK parameters- Cmax (maximum serum concentration)

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

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

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

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

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

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biora Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: