[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Op-T LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100590182","phase-2-pharmacokinetic-and-early-efficacy-of-opt101-in-patients-with-type-1-diabetes-mellitus-100590182",false,"NCT06964087","Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus","A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n* 1\\. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).\n\n  2\\. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).\n\n  3\\. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4. Diagnosis of T1DM within the last 20 years for Part A, within 1 to 10 years \\[N=15 at \\>5 to 10, N=12 at 1 to 5 yrs\\] for Part B, within less than or equal to 1 year for Part C.\n\n  5\\. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).\n\n  6\\. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.\n\n  7\\. Women of childbearing potential (WOCBP) must have a negative highly sensitive serum test (beta- human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.\n\n  8\\. WOCBP must agree to use one of the following methods of birth control for the duration of the clinical trial: Systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.\n\nExclusion Criteria:\n\n* 1\\. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.\n\n  2\\. Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia.\n\n  3\\. Has chronic kidney disease of Stage 2 or higher with eGFR of \\\u003C90 mL\u002Fmin\u002F1.73m2.\n\n  4\\. Is currently receiving an immuno-modulatory treatment. 5. Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following:\n  1. Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.\n  2. Patients with recent immobilization or recent surgery.\n  3. Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome.\n\n     6\\. Has an active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus, cytomegalovirus, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii pneumonia, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer.\n\n     7\\. Has recent or active hepatitis A infection, current\u002Fchronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection, defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody \\[anti-HBs\\] or vaccination \\[defined as negative HBsAg, negative anti-HBc, and positive anti-HBs\\] are eligible to participate.\n\n     8\\. Has a history of latent or active tuberculosis. 9. Has received a live attenuated vaccine within the last 60 days including patients who plan to receive live attenuated vaccines during the study or within 60 days after the final dose of study treatment.\n\n     10\\. Patients with the following should be excluded:\n\n  \u003C!-- -->\n\n  1. Abnormal coagulation test at screening: prothrombin time (PT; \\>14 sec), activated partial thromboplastin time (aPTT; \\>32 sec) or fibrinogen level (\\\u003C190 or \\>450 mg\u002FdL).\n  2. Abnormal liver function tests (except in the case of known Gilbert's syndrome):\n\n  i. AST or ALT ≥3x ULN and total bilirubin ≥2x ULN ii. AST or ALT ≥5x ULN iii. Abnormal platelet counts (\\\u003C150 or \\> 450 x10 to the third\u002FuL) iv. Abnormal white blood cell counts (\\\u003C 3.0 or \\>11.0 x10 to the third\u002FuL ) v. Abnormal eGFR (\\\u003C 90 mL\u002Fmin) vi. Abnormal Factor VIII (\\\u003C50% or \\>150% of normal) vii. Abnormal D-Dimer (\\> 500 ng\u002FmL of fibrinogen equivalent units (FEU)) 11. Patients planning to undergo elective procedures or surgeries at any time after signing the ICF through the follow-up visit.\n\n  12\\. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.\n\n  13\\. Recent history of bleeding or bleeding disorders or any condition whereby in the opinion of the treating investigator giving anti-coagulation during treatment would be contraindicated.\n\n  14\\. History of hypersensitivity to antihistamines. 15. Body mass index \\\u003C20 or \\>35 kg\u002FM2 16. Patients with active drug or alcohol abuse within one year prior to screening or patients who test positive for required drug testing during screening (refer to §8.4).\n\n  17\\. Patient is participating in a clinical trial of another investigational drug or device, including patients who have participated in another study for duration of 5 half-lives of the investigational agent.\n\n  18\\. Patient is a prisoner. 19. Patients with any medical condition, including, but not limited to, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or a psychiatric condition that, in the opinion of the Investigator, could compromise their ability to participate in this study.","ALL","18 Years","50 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.",[27],"Type I Diabetes","RECRUITING","2026-04-02",{"date":31,"type":32},"2026-04-06","ACTUAL",{"date":34,"type":21},"2026-04-10",{"date":36,"type":21},"2028-08-19",{"name":38,"class":39},"Op-T LLC","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100567531","phase-1-opt101-in-patients-with-community-acquired-pneumonia-cap-with-sepsis-100567531","NCT06669403","OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis","A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis","Inclusion Criteria:\n\n1. Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed).\n2. ≥18 years old;\n3. Patients hospitalized for clinically suspected community acquired pneumonia (CAP), defined as the occurrence of (within 48h from hospital admission) at least 1 of the following signs:\n\n   * respiratory rate \\> 30 breaths\u002Fmin;\n   * fever (\\> 38.0°C or \\> 100.4° F);\n   * leukopenia (≤ 4,000 WBC\u002Fmm3 or leukocytosis (≥ 12,000 WBC\u002Fmm3);\n   * adults ≥ 70 years of age; altered mental status with no other recognized cause;\n\n   AND at least 1 of the following:\n   * New onset of purulent sputum or change in character of sputum or increased respiratory secretions;\n   * New onset or worsening cough, or dyspnea, or tachypnea;\n   * Rales or bronchial breath sounds; AND Radiologic imaging (chest x-ray or CT scan) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation AND SpO2 \\\u003C92% at room air, or PaO2\u002FFiO2 (or SpO2\u002FFiO2) \\\u003C300; recorded on one episode\n4. Need for non-invasive supplemental oxygen (nasal cannula, simple mask, venturi or reservoir cannula\u002Fmask or heated high flow nasal cannula oxygen.\n5. Females of child-bearing potential who are sexually active must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:\n\n   * Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last OPT101 dose\n   * A non-hormonal intrauterine device \\[IUD\\] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last OPT101 dose\n   * A male sexual partner who agrees to use a male condom with spermicide\n   * A sterile sexual partner\n\nExclusion Criteria:\n\n1. Need for endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at time of study screening\n2. QTc ≥ 450 msec on screening ECG\n3. Hepatic dysfunction: ALT or AST \\> 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score ≥ 12)\n4. Recent or active hepatitis A infection; test positive or have been treated for hepatitis B, hepatitis C, or HIV infection; evidence of active or untreated latent TB; a recent history of recurrent herpes zoster and\u002For opportunistic infection; and\u002For taking immunosuppressant medication.\n5. Renal dysfunction: estimated glomerular filtration rate (eGFR) \\\u003C50 mL\u002Fmin\u002F1.73 m2, or need for hemodialysis or hemofiltration\n6. Current use of \\>2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC \\\u003C local LLN), solid organ or bone marrow transplant recipients)\n7. Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period\n8. Anticipated discharge from the hospital or transfer to another hospital within 48 hours of screening\n9. Allergy to OPT101or any component of OPT101 formulation\n10. Participation in other interventional clinical trials\n11. Pregnancy:\n\n    * positive or missing pregnancy test before first drug intake or day 1\n    * pregnant or lactating women;\n    * Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study\n12. Current hospital stay \\>72h\n13. Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism\n14. Weight is over 250lbs\n15. Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study. The Principal Investigator should make this determination in consideration of the patient's medical history and current clinical condition.\n\n    \\-",{"count":49,"type":21},26,[51],"PHASE1","OPT101-100-40 is a multicenter, randomized, placebo-controlled, multiple-ascending-dose, sequential-group, investigator- and participant-blinded, sponsor-unblinded, study of OPT101 vs placebo when administered for up to 4 days to patients admitted to the hospital for treatment of Community Acquired Pneumonia (CAP) with sepsis.\n\nThis study will be performed in patients with Community Acquired Pneumonia (CAP) with Sepsis, who are 18 years or older to evaluate the safety and tolerability of OPT101 in a population with elevated levels of pathologic CD40.",[54,55],"Sepsis","Community Acquired Pneumonia (CAP)",[54,55,57,58,38],"Immunomodulator","OPT101","NOT_YET_RECRUITING","2025-09-08",{"date":62,"type":32},"2025-09-15",{"date":64,"type":21},"2025-12",{"date":66,"type":21},"2026-05",{"name":38,"class":39},1,""]