[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"1ST Biotherapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100497744","phase-1-a-phase-iii-open-label-study-to-investigate-the-safety-tolerability-pk-and-preliminary-efficacy-of-fb849-100497744",false,"NCT05761223","A Phase I\u002FII, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849","A Phase I\u002FII, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab","Inclusion Criteria:\n\n* Subject should understand, sign, and date the written ICF prior to screening.\n* Male or female aged 18 years or older.\n* Subjects must have at least 1 measurable target lesion according to RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Life expectancy ≥ 3 months in the opinion of the investigator.\n* Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study treatment\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the study treatment.\n* Has a known additional malignancy that is progressing or has required active treatment.\n* Has abnormal or inadequately controlled endocrine function.\n* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.\n* Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy, or other investigational drugs received ≤ 4 weeks; endocrine therapy ≤ 2 weeks or ≤ 5-half-lives (whichever is shorter) prior to initiation of study treatment.","ALL","18 Years",{"count":19,"type":20},151,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is the first-in-human, multicenter, open-label Phase I\u002FII study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of FB849 alone and in combination with pembrolizumab in subjects with advanced solid tumors for whom no standard therapy is available.",[27],"Advanced Solid Tumor","RECRUITING","2025-08-13",{"date":31,"type":32},"2025-08-17","ACTUAL",{"date":34,"type":32},"2023-12-13",{"date":36,"type":20},"2026-10",{"name":38,"class":39},"1ST Biotherapeutics, Inc.","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100602683","phase-1-a-phase-1-sad-and-mad-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-oral-fb-101-in-healthy-adult-male-subjects-100602683","NCT07126704","A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects","Key Inclusion Criteria:\n\n1. Healthy, adult, male 19-55 years of age, inclusive, at screening.\n2. A continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self-reporting.\n3. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg\u002Fm2 at screening.\n4. Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, clinical laboratory profiles, vital signs, or safety 12-lead ECGs, as deemed by the PI or designee.\n5. A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after (the last) dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to (the first) dosing of the investigational product. A male who has been vasectomized less than 4 months prior to study (first) dosing must follow the same restrictions as a non-vasectomized male).\n6. Must agree not to donate sperm from the first dosing until 90 days after the last dosing.\n7. Able to swallow multiple capsules.\n\nKey Exclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. Is at suicidal risk in the opinion of the PI or designee.\n4. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subject by their participation in the study.",true,"MALE","19 Years","55 Years",{"count":53,"type":20},72,[23],"This is a Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration.\n\nUp to 72 healthy adult male subjects will be enrolled. Additional subjects may be enrolled (8 subjects per cohort) if it is deemed appropriate following review (e.g., in the circumstances where a dose level is repeated, or an intermediate dose is conducted or to add another dose level(s) (higher than those planned)).",[57],"Healthy","NOT_YET_RECRUITING","2025-08-11",{"date":31,"type":32},{"date":62,"type":20},"2025-11",{"date":64,"type":20},"2027-06",{"name":38,"class":39},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":48,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":66},"100515767","phase-1-a-phase-1-sad-and-mad-study-to-evaluate-the-safety-and-tolerability-of-fb418-100515767","NCT05995782","A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral FB418 in Healthy Adult Subjects and Healthy Elderly Subjects","Key Inclusion Criteria:\n\n1. Healthy, adult, male 19 55 years of age, inclusive, at the screening.\n2. For elderly subjects(Part A Cohort 5 only), healthy, elderly, male or female (of non childbearing potential only) over 60 years of age, inclusive, at screening.\n3. In the case of the elderly(Part A Cohort 5 only), they have a history of mild disease, but can participate if the researcher judges that they can stop taking the drug at least 2 weeks before the expected first dose or before the half-life is 5 times or more)\n4. The continuous non smoker who have not used nicotine containing products for at least 3 months prior to (the first) dosing and throughout the study are based on subjective self reporting.\n5. Body mass index (BMI) ≥ 18 and ≤ 32 kg\u002Fm2 at the screening.\n6. Medically healthy with no clinically significant medical history, physical examination, simplified neurological examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.\n7. In Cohort 5, A female subject must be of non childbearing potential\n\nKey Exclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.\n4. Is at suicidal risk in the opinion of the PI as per the following criteria:\n\n   1. Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening.\n   2. C-SSRS answer of \"YES\" on suicidal ideation within 3 months prior to screening.\n5. History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing.\n6. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.\n7. History of seizures (childhood febrile seizures are excepted).\n8. Positive urine drug or alcohol results at screening or check in.\n9. Has an abnormal screening ECG indicating a second- or third- degree AV block, or one or more of the following: QRS \\> 120 msec, QTcF \\> 450 msec for males and \\> 460 msec for females, PR interval \\> 220 msec. Any rhythm other than normal sinus rhythm, which is interpreted by the PI or designee to be clinically significant at screening or check-in.\n10. Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.",{"count":75,"type":20},64,[23],"The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.",[79,80],"Parkinson Disease Psychosis","Amyotrophic Lateral Sclerosis (ALS)","2024-11-27",{"date":83,"type":32},"2024-12-02",{"date":85,"type":32},"2023-12-20",{"date":87,"type":20},"2024-12",{"name":38,"class":39},""]