[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biora Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100658373","phase-1-an-early-feasibility-study-of-the-biojet-oral-biotherapeutic-delivery-system-for-administration-of-therapeutic-agents-in-healthy-participants-100658373",false,"NCT07849153","An Early Feasibility Study of the BioJet™ Oral Biotherapeutic Delivery System for Administration of Therapeutic Agents in Healthy Participants","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","Inclusion Criteria:\n\n* Body mass index between ≥ 18.0 and ≤ 32.0 kg\u002Fm2 and weight ≥ 50 kg\n* Not pregnant or breastfeeding, or willing to cease breastfeeding.\n* 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.\n* Males must agree to not donate sperm from the first dose of IP until at least 5 months after the last dose of IP.\n* WOCBP must agree to not donate ova from the first dose of IP until at least 5 months after the last dose of IP.\n* 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.\n\nExclusion Criteria:\n\n* History of chronic inflammatory or autoimmune disease requiring immunosuppressive therapy.\n* History or presence of any clinically significant medical condition, including:\n\n  1. Dysphagia, achalasia, or swallowing disorders, including difficulty in swallowing oral medication.\n  2. Zenker's diverticulum.\n  3. 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.\n  4. Gastrointestinal (GI) diverticular disease.\n  5. Gastric, small bowel, and\u002For colonic resections, strictures, and\u002For obstructions.\n  6. History of inflammatory bowel disease including Crohn's disease or ulcerative colitis.\n  7. Gastrointestinal surgery (e.g., gastrectomy, laparoscopic banding, Roux-en-Y).\n  8. Radiation or chemotherapy-induced enteritis.\n  9. Abdominal or pelvic surgery that could impair GI transit per the opinion of the Investigator (history of appendectomy or cholecystectomy are permitted).\n  10. Symptomatic hiatal hernia.\n  11. Known history of bezoars.\n  12. Recent history of peptic ulcer disease within 6 months.\n  13. History of cardiovascular, hepatic, renal, pulmonary, GI, neurologic, hematologic, endocrine, psychiatric, or autoimmune disease.\n  14. Any significant skin condition or extensive tattoos of the lower abdomen that is likely to impede SC injection or injection-site assessment.\n* Evidence of active or latent TB, including:\n\n  * Positive TB screening test (Interferon-Gamma Release Assay \\[IGRA\\]),\n  * History of untreated or inadequately treated latent or active TB.\n* History of malignancy, except adequately treated non-melanoma skin cancer.\n* Use of systemic corticosteroids, immunosuppressants, or immunomodulators within 7 days or 5 half-lives of the drug (whichever is longer) prior to dosing.\n* History of demyelinating disease (e.g., multiple sclerosis, optic neuritis).\n* History of congestive heart failure or clinically significant cardiac disease.\n* Positive drug or alcohol screening test.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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.\n\nThe 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.\n\nApproximately 30 healthy adults will take part in this study.",[28],"Healthy Subjects","NOT_YET_RECRUITING","2026-09-24",{"date":32,"type":33},"2026-09-30","ACTUAL",{"date":35,"type":22},"2026-10-20",{"date":37,"type":22},"2027-02-15",{"name":39,"class":40},"Biora Therapeutics, Inc.","INDUSTRY",""]