[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Syneos Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100631194","phase-1-a-study-of-b-3e07-and-forsteo-in-healthy-adult-female-participants-100631194",false,"NCT07497503","A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants","A Randomised, Double-Blind, Two-Sequence, Single-Dose, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of B-3E07 and Forsteo in Healthy Adult Female Participants","Inclusion Criteria:\n\n1. Healthy adult Caucasian female volunteers, 18-45 years of age, inclusive, at the time of consent.\n2. Body Mass Index (BMI) greater than (\\>)18.5 and less than or equal to (\\\u003C=) 30.0 kilograms per square meter (kg\u002Fm\\^2) (inclusive) at the time of screening.\n3. Body weight greater than or equal to (\\>=) 45.0 kilograms (kg) at the time of screening.\n4. The participant is considered by the investigator to be in good general health, defined as absence of clinically significant illness or surgery within 4 weeks prior to dosing, and no clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease as determined by medical history, clinical laboratory test results vital sign measurements (systolic blood pressure \\[BP\\] \\>=90 millimiters of mercury \\[mmHg\\] and \\\u003C=145 mmHg, diastolic BP \\>=50 mmHg and \\\u003C=95 mmHg), 12-lead ECG results, and physical examination findings at screening and check-in (congenital nonhaemolytic hyperbilirubinemia \\[for example Gilbert's syndrome\\] and\u002For abnormal findings without clinical significance are acceptable).\n5. Absence of tattoos, scars, or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with the evaluation of injection reaction.\n6. All participants of childbearing potential must have a negative pregnancy test at screening and check-in and must agree to use a highly effective method of contraception from screening through study completion and for 30 days after the last dose. Acceptable highly effective methods of contraception include intrauterine device (IUD)\u002F intrauterine system (IUS), bilateral tubal occlusion, exclusive relationship with a vasectomized partner with documented azoospermia, sexual abstinence (if this is the participant's usual lifestyle) or exclusively engaging in a same-sex relationship. Male partners of female participants should also use a condom. Hormonal methods for contraception (including a hormone-releasing intrauterine system such as Mirena) or double-barrier methods (e.g., male condom with diaphragm or cervical cap) are not permitted.\n7. The participant must be able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. Participants must have signed an ICF before any study-related procedure or evaluation is performed.\n\nExclusion Criteria:\n\n1. Corrected serum calcium and\u002For alkaline phosphatase (ALP) above the upper limit of normal (ULN) at screening and check-in.\n2. Clinically significant abnormal parathyroid hormone (PTH) level and\u002For total cholesterol above the upper limit of normal (ULN) range or 25 hydroxyvitamin D (25OH-Vit D) less than the lower limit of normal range at screening.\n3. Haemoglobin less than (\\\u003C)12 grams per decilitre (g\u002FdL) or haematocrit \\\u003C0.32, or there is any active bleeding at screening and at check-in.\n4. Positive results for hepatitis B surface antigen \\[HBsAg\\] and total hepatitis B core antibody \\[anti-HBc\\]) at screening. Participants with immunity to hepatitis B from previous natural 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) may be included in the study.\n5. Positive results for hepatitis C (HCV) and\u002For Positive results for human immunodeficiency (HIV) at screening.\n6. Positive urine drug screen (Amphetamine, Benzodiazepine, Cocaine, Methamphetamines, Opiates, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Alcohol, Fentanyl, Tramadol, Tricyclic Antidepressants, Barbiturates, Methadone, Oxycodone, Phencyclidine) -and\u002For positive breath alcohol test at screening and check-in.\n7. Lactating or known pregnant or positive result for serum human chorionic gonadotropin (HCG) test at screening and at check-in.\n8. Postmenopausal women.\n9. History or presence of bone diseases including, but not limited to, Paget's disease of bone, bone carcinoma, metastases in the bone, metabolic bone disease, known osteoporosis (except for history of traumatic bone fracture at least 90 days prior to screening) at screening.\n10. History within the past 5 years and\u002For presence of any significant endocrine (including thyroid and parathyroid gland) disease at screening.\n11. Known active urolithiasis at screening.\n12. Estimated glomerular filtration rate (eGFR) \\\u003C90 milliter per minutes per 1.73 square meter (mL\u002Fmin\u002F1.73m\\^2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method or clinically significant renal disease as judged by the Investigator.\n13. History of sensitivity to study drug or its components or Escherichia coli (E. coli) derived proteins.\n14. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator.\n15. History within the past 90 days of continuous use (for at least 2 weeks) of any drugs or supplements affecting bone metabolism (such as bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulators (SERMs), parathyroid hormone and its analogues, strontium salts, fluoride, active vitamin D and its analogues, vitamin K2, calcium supplements, etc.) at screening.\n16. History of using any prescription, nonprescription medications\u002Fproducts, herbal remedies, supplements at screening. Use of Paracetamol up to 2 grams (g) daily and other over-the-counter medications (antihistamines, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)) up to 72 hours prior to admission as long as more than 5 half-lives have elapsed and the investigator approves, and topical or intranasal medication with limited systemic absorption is allowed.\n17. History within 3 months of external beam or implant radiation therapy involving the skeleton reported at screening.\n18. Donated or lost 500 milliliters (mL) or more of whole blood, or received a blood transfusion, or used blood products within 8 weeks prior to dosing.\n19. History of alcohol abuse within the past 5 years (defined as drinking more than or equal to 14 units of alcohol per week: 1 unit approximately (≈) 285 ml of beer, or 25 ml of spirits, or 100 ml of wine), or an unwillingness to adhere to visit window alcohol restrictions, or to refrain from illicit drugs throughout the study.\n20. History of drug abuse within 6 months prior to Screening, defined as non-medical use of substances to achieve psychoactive effects, as determined by medical history, Investigator assessment, and \u002For positive drug screen.\n21. History or evidence of habitual use of tobacco- or nicotine-containing products (more than 5 cigarettes per day on average) within 90 days prior to Screening and unwillingness to abstain throughout the study.\n22. Previous enrolment in any other drug, device clinical study within 30 days or 5 times the half-life of the drug used in the previous study (whichever was longer) prior to Screening, or plan to take part in other clinical studies during this study.\n23. Unable to refrain from using foods and beverages containing xanthines\u002Fcaffeine for at least 48 hours before each investigational medicinal product (IMP) dosing and throughout the inpatient period.\n24. Unable to refrain from using foods and beverages containing alcohol for at least 24 hours before each IMP dosing and throughout the inpatient period.\n25. The participant has poor peripheral venous access.\n26. Participants who, in the opinion of the investigator, should not participate in this study.",true,"FEMALE","18 Years","45 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The main aim of the study is to evaluate the pharmacokinetic (PK) biosimilarity of B-3E07 and European Union (EU) - sourced Forsteo® in healthy adult female participants.",[28],"Healthy Volunteers",[30,31,32,33],"Crossover","Pharmacokinetics","Immunogenicity","Bio similarity","RECRUITING","2026-05-11",{"date":37,"type":38},"2026-05-14","ACTUAL",{"date":40,"type":38},"2026-04-10",{"date":42,"type":22},"2026-06-24",{"name":44,"class":45},"Syneos Health","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":46},"100088058","antiretroviral-pregnancy-registry-apr-multi-sponsor-registry-to-detect-any-major-teratogenic-effect-involving-any-of-the-registry-drugs-when-administered-to-pregnant-people-100088058","NCT00404989","Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.","Antiretroviral Pregnancy Registry","APR","Eligibility Ages Eligible for Study: People of childbearing potential\n\nInclusion Criteria:\n\n* Country of origin of report\n* Documentation that the registry drug was taken during pregnancy\n* Sufficient information to determine if the pregnancy is being prospectively or retrospectively registered\n* Date the pregnancy was registered\n* Source of report (patient or health care provider)\n* Whether the pregnancy outcome is already known or delivery is still pending\n* Timing of the prenatal exposure to the registry medication (no broader than which trimester)\n* Sufficient patient identifier relevant to reporter to allow for follow-up\n* Was patient involved in a study at the time of prenatal exposure\n* Full reporter contact information (name, address, etc.)\n\nExclusion Criteria:\n\n• People who were not exposed to registry medications during pregnancy","12 Years","60 Years",{"count":58,"type":22},24258,"OBSERVATIONAL","The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant people. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies.\n\nGiven the increasing number of medications and more aggressive approach to therapy, more HIV- and hepatitis B-infected people may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies.\n\nEach year the Registry has enrolled approximately 1300-1700 pregnant people in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive people who give birth to live infants annually in the US.",[62,63],"HIV Infections","Hepatitis B",[65,66,67,68,69],"HIV","HBV","Hepatitis","Pregnancy","Registry","2025-03-26",{"date":72,"type":38},"2025-04-01",{"date":74,"type":4},"1989-01",{"date":76,"type":22},"2099-01",{"name":44,"class":45},""]