Healthy SubjectsPhase 1NCT07849153
An Early Feasibility Study of the BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy Participants
A Phase 1 study testing Hadlima® in people with Healthy Subjects, run by Biora Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Hadlima®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 15 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Any significant skin condition or extensive tattoos of the lower abdomen that is likely to impede SC injection or injection-site assessment.
- Evidence of active or latent TB, including:
- Positive TB screening test (Interferon-Gamma Release Assay [IGRA]),
- History of untreated or inadequately treated latent or active TB.
- History of malignancy, except adequately treated non-melanoma skin cancer.
- Use of systemic corticosteroids, immunosuppressants, or immunomodulators within 7 days or 5 half-lives of the drug (whichever is longer) prior to dosing.
- History of demyelinating disease (e.g., multiple sclerosis, optic neuritis).
- History of congestive heart failure or clinically significant cardiac disease.
- Positive drug or alcohol screening test.
About 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
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
- Being tested
- Hadlima®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Hadlima® Group 1 | Experimental | Not described Receives: Drug: Hadlima® |
| Hadlima® Group 2 | Active comparator | Not described Receives: Drug: Hadlima® |
| Hadlima® Group 3 | Active comparator | Not described Receives: Drug: Hadlima® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs
Measured: From Day 1 to day 30 (EOT visit)
Incidence of SAEs
Measured: From Day 1 to day 30 (EOT visit)
Number of participants with abnormal vital signs
Measured: Days 1, 2,3,8,15 and day 30 (EOT visit)
Number of participants with abnormal Physical examination findings
Measured: From Day 1 to day 30 (EOT visit)
Number of participants with abnormal ECG readings
Measured: Days 1, 2 and Day 3
Number of participants with abnormal Laboratory findings
Measured: Days 1,3,8,15 and Day 30 (EOT visit)
Secondary outcomes (4)
Plasma PK parameters- Cmax (maximum serum concentration)
Measured: Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
Plasma PK parameters- Tmax (time to maximum serum concentration)
Measured: 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)
Measured: 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)
Measured: Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biora Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Connell, Dr., Principal investigator, CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849153
- Sponsor's protocol ID
- FIH-AUS 110
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07849153
- Acronym / sponsor ID
- FIH-AUS 110
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Biora Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hadlima® Group 1 | Experimental | Drug: Hadlima® |
| Hadlima® Group 2 | Active comparator | Drug: Hadlima® |
| Hadlima® Group 3 | Active comparator | Drug: Hadlima® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- History of chronic inflammatory or autoimmune disease requiring immunosuppressive therapy.
- History or presence of any clinically significant medical condition, including:
- Evidence of active or latent TB, including:
- History of malignancy, except adequately treated non-melanoma skin cancer.
- Use of systemic corticosteroids, immunosuppressants, or immunomodulators within 7 days or 5 half-lives of the drug (whichever is longer) prior to dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hadlima®Route of administration: via BioJet™ device oral capsule Dose: 30 mg | Drug | Hadlima® Group 1 |
| Hadlima®Route of administration: by SC injection Dose: 20 mg | Drug | Hadlima® Group 2 |
| Hadlima®Route of administration: by SC injection Dose: 40 mg | Drug | Hadlima® Group 3 |
Primary outcome
Incidence of TEAEs
Time frame: From Day 1 to day 30 (EOT visit)
Incidence of SAEs
Time frame: From Day 1 to day 30 (EOT visit)
Number of participants with abnormal vital signs
Time frame: Days 1, 2,3,8,15 and day 30 (EOT visit)
Number of participants with abnormal Physical examination findings
Time frame: From Day 1 to day 30 (EOT visit)
Number of participants with abnormal ECG readings
Time frame: Days 1, 2 and Day 3
Number of participants with abnormal Laboratory findings
Time frame: Days 1,3,8,15 and Day 30 (EOT visit)
4 secondary outcomes
Plasma PK parameters- Cmax (maximum serum concentration)
Time frame: Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
Plasma PK parameters- Tmax (time to maximum serum concentration)
Time frame: 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)
Time frame: 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)
Time frame: Days 1,2,3,4,6,8,15 and Day 30 (EOT visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Connell, Dr. principal investigator
CMAX Clinical Research Pty Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hadlima® in people with Healthy Subjects, run by Biora Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (time frame: From Day 1 to day 30 (EOT visit)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.