Phase
Condition
Osteoporosis
Hypoparathyroidism
Treatment
EBP11-M
Forteo 20 mg
EBP11
Clinical Study ID
Ages 18-35 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy male subjects, 18 - 35 years of age, inclusive, at screening.
Continuous nonsmoker who has not used nicotine containing products (includinge-cigarettes, vapors, etc.) for at least 12 months prior to first dosing andthroughout the study, based on subject self-reporting.
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
Medically healthy with no clinically significant medical condition, physicalexamination, laboratory profiles, vital signs, orthostatic vital sign measurements,or ECGs, as deemed by the PI or designee to be relevant to the study and does notpose an additional risk to the subject by their participation in the study.
Understands the study procedures described in the Informed Consent Form (ICF), bewilling and able to comply with the protocol, and provides written consent.
Exclusion
Exclusion Criteria:
History or current condition of mental instability or cognitive impairment that, inthe opinion of the investigator, could compromise the validity of informed consent,compromise the safety of the participant, or lead to nonadherence with the studyprotocol or inability to conduct the study procedures.
Active gastrointestinal inflammatory disorder, gastrointestinal motility disorders,and chronic gastritis, including but not limited to: ulcerative colitis, Crohn'sdisease, irritable bowel syndrome, short bowel syndrome, celiac disease,gastroparesis, that may affect drug bioavailability.
Any conditions or factors that, in the judgment of the PI or designee, somehow mayimpact gastrointestinal absorption, distribution or metabolism of parathyroidhormone analogues, or known to potentiate or predispose to undesired effects.
History of significant gastrointestinal, liver or kidney disease, orgastrointestinal surgery (including bariatric surgery, or any other interventionalprocedures with stomach and intestinal tract) that may affect either drugbioavailability, or hPTH(1-34) or SNAC metabolism.
History or presence of alcohol or drug abuse or positive urine drug or blood alcoholresults at screening.
Known allergies or sensitivities to components of the Study Medication (e.g. soy) orknown hypersensitivity to PTH or hPTH(1-34).
History or presence of clinically significant:
Urolithiasis;
Angina at Screening, in the opinion of the PI;
Hypocalcemia or hypercalcemia at screening;
Personal or family history of congenital long QT syndrome or known familyhistory of sudden death.
- Subjects with ECG findings deemed abnormal with clinical significance by the PI ordesignee at screening for the following:
QTcF interval > 470 msec;
PR > 220 msec;
QRS > 120 msec.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis Bsurface antigen (HBsAg) or hepatitis C virus (HCV).
Seated blood pressure is less than 90 systolic or 40 diastolic mmHg or greater than 140 systolic or 90 diastolic mmHg at screening;
Orthostatic vital sign results with a decrease in systolic > 20 mmHg or decrease indiastolic > 10 mm Hg, and/or increase in heart rate of > 20 beats per minute atscreening or Day 1 check-in.
Seated heart rate is lower than 50 bpm or higher than 99 bpm at screening (whenclinically significant as determined by PI).
Estimated creatinine clearance < 80 mL/min at screening
Unable to refrain from or anticipates the use of:
Any drug, including prescription and nonprescription medications, herbalremedies, or vitamin supplements that should be taken on the treatment visitday before the dosing of Study Medication and 2 hours after the dosing of StudyMedication.
H2 blocker or PPI or antacid (including prescription and nonprescription) threedays before the dosing of the Study Medication and 2 hours after the dosing ofStudy Medication.
Donation of blood or significant blood loss within 56 days prior to first dosing.
Hemoglobin levels below 13 g/dL at screening or at in screening test done during thestudy.
Plasma donation within 7 days prior to first dosing.
Participation in another interventional clinical study within 30 days prior toscreening visit.
Study Design
Connect with a study center
Clinical Research Center Hadassah Ein Kerem Medical Center
Jerusalem, 91120,
IsraelSite Not Available
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