A Study of TEPEZZA Subcutaneous Administration in Healthy Adults
- Conditions
- BioavailabilityBioequivalence
- Registration Number
- NCT06563856
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria:<br><br> - The participant is able to provide written informed consent.<br><br> - The participant is male or female 18 to 55 years of age, inclusive.<br><br> - The participant has a body mass index (BMI) between 21 to 30 kg/m^², inclusive, and<br> a minimum weight of 55 kg at Screening.<br><br> - The participant is considered by the investigator or designee to be in good general<br> health as determined by medical history, clinical laboratory test results, vital<br> sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination<br> findings at Screening.<br><br> - The participant has adequate venous access and can receive IV therapy.<br><br> - Female participants of childbearing potential must have a negative serum pregnancy<br> test at Screening and Check-in and negative urine pregnancy tests at all other<br> protocol-specified time points. Participants who are sexually active with a<br> non-vasectomized male partner must agree to use 2 reliable forms of contraception<br> during the study, one of which is recommended to be hormonal, such as an oral<br> contraceptive.<br><br> - Female participants must agree not to donate an egg/oocyte from Day 1 until 180 days<br> after receiving the study drug.<br><br>Male participants must agree not to donate sperm from Day 1 until 180 days after<br>receiving the study drug.<br><br>-The participant is willing and able to comply with all protocol requirements and<br>evaluations for the duration of the study.<br><br>Exclusion Criteria:<br><br> - The participant has a positive test result for hepatitis B surface antigen,<br> hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) types 1 or 2<br> antibodies at Screening.<br><br> - The participant has a diagnosis of an autoimmune disease; or a history of HIV,<br> hepatitis B virus (HBV), or HCV infection; a history of inflammatory bowel disease<br> (IBD), or a history of or active thyroid eye disease (TED) at Screening.<br><br> - The participant has active liver disease or hepatic dysfunction at Screening or<br> Check-in, as determined by alanine aminotransferase (ALT) or aspartate<br> aminotransferase (AST) levels >1.5 times upper limit of normal (ULN).<br><br> - The participant has glycated hemoglobin (HbA1c) levels =8% and/or fasting glucose<br> levels (after at least an 8-hour fast) >126 mg/dL (>7 mmol/L) at Screening.<br><br> - The participant has a seated resting blood pressure of <90/40 mmHg or >140/90 mmHg,<br> or a seated pulse rate of <40 beats per minute (bpm) or >99 bpm or is considered<br> clinically significant at Screening. One additional measurement can be taken if<br> blood pressure and pulse rate are outside the specified limits.<br><br> - The participant has clinically significant 12-lead ECG abnormalities at Screening<br> and Check-in or, in the opinion of the investigator, has a second- or third-degree<br> atrioventricular (AV) block, or has any of the following:<br><br>QRS >120 msec<br><br>QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec (males)<br>or >470 msec (females)<br><br>PR interval >220 msec<br><br> - The participant has used any prescription (excluding hormonal birth control) or<br> over-the-counter medications (except paracetamol [up to 2 g per day]), including<br> herbal or nutritional supplements, within 14 days before receiving the study drug.<br><br> - The participant has a medical condition associated with an increased risk of<br> bleeding - including a history of hematological diseases such as acquired platelet<br> disorders; coagulation disorders - including drug-induced thrombocytopenia,<br> idiopathic thrombocytopenia, or von Willebrand's Disease; or requires the use of<br> antiplatelet or anticoagulant medication.<br><br> - Female participants who are lactating or planning to become pregnant from Screening<br> through 180 days after receiving the study drug.<br><br> - Male participants who are planning to impregnate a female partner from Day 1 through<br> 180 days after receiving the study drug.<br><br> - The participant has consumed alcohol-, caffeine-, or xanthine-containing products<br> within 48 hours before the dose of study drug.<br><br> - The participant is a smoker or has used nicotine or nicotine-containing products<br> (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers)<br> within 3 months before receiving the study drug.<br><br> - The participant has a history of alcohol abuse or drug addiction within the past 6<br> months prior to Day 1 dosing.<br><br> - The participant has a positive test result for drugs of abuse, alcohol, or cotinine<br> (indicating active current smoking) at Screening or before receiving the study drug.<br><br> - The participant is involved in strenuous activity or contact sports within 24 hours<br> before receiving the study drug and during the study.<br><br> - The participant has donated blood, had significant blood loss, or received a<br> transfusion of any blood or blood products within 60 days prior to Day 1 dosing or<br> received a plasma donation within 7 days prior to Day 1 dosing.<br><br> - The participant has a history of relevant drug and/or food allergies (i.e., allergy<br> or idiosyncratic reaction to components of TEPEZZA or excipients; prior<br> hypersensitivity reactions to mAbs, EDP, or excipients; or any significant food<br> allergy that could preclude a standard diet in the clinical unit).<br><br> - The participant participated in another investigational study within 30 days (or 5<br> half-lives of the study drug, whichever is longer) prior to dosing on Day 1. The<br> 30-day window will be derived from the date of the last blood collection or dosing,<br> whichever is later, in the previous study to the date of Day 1 of the current study.<br><br> - The participant has previously participated in a TEPEZZA investigational study or<br> has received TEPEZZA or rHuPH20-containing products.<br><br> - The participant has received a COVID-19 vaccination within 6 weeks before receiving<br> the study drug or during the study.<br><br> - The participant has a positive test for severe acute respiratory syndrome<br> coronavirus 2 (SARS-CoV-2). Note: Testing will be performed according to site<br> procedures.<br><br> - The participant is mentally or legally incapacitated or has significant emotional<br> problems at Screening or is expected to have them during the conduct of the study.<br><br> - The participant has a history or presence of a clinically significant medical or<br> psychiatric condition or disease in the opinion of the investigator or designee.<br><br> - The participant had a history of any illness that, in the opinion of the<br> investigator or designee, might confound the results of the study or pose an<br> additional risk to the participant by participation in the study.<br><br> - In the opinion of the investigator or designee, the participant is not suitable for<br> entry into the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort 1, 2, and 4: Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of TEPEZZA;Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA;Cohort 1, 2, and 4: Percentage of the Area Extrapolated for Calculation of AUCinf (%AUCextrap) of TEPEZZA;Cohort 1, 2, and 4: Maximum Observed Serum Concentration (Cmax) of TEPEZZA;Cohort 1, 2, and 4: Last Quantifiable Serum Concentration (Clast) of TEPEZZA;Cohort 1, 2, and 4: Time to Maximum Observed Serum Concentration (Tmax) of TEPEZZA;Cohort 1, 2, and 4: Time of Last Quantifiable Serum Concentration (Tlast) of TEPEZZA;Cohort 1, 2, and 4: Apparent Terminal Elimination Rate Constant (?z) of TEPEZZA;Cohort 1, 2, and 4: Apparent Terminal Half-life (t1/2) of TEPEZZA;Cohort 1, 2, and 4: Apparent Serum Clearance (CL/F) of TEPEZZA;Cohort 1, 2, and 4: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of TEPEZZA
- Secondary Outcome Measures
Name Time Method Cohort 3: AUCinf of TEPEZZA;Cohort 3: AUClast of TEPEZZA;Cohort 3: %AUCextrap of TEPEZZA;Cohort 3: Cmax of TEPEZZA;Cohort 3: Clast of TEPEZZA;Cohort 3: Tlast of TEPEZZA;Cohort 3: ?z of TEPEZZA;Cohort 3: t1/2 of TEPEZZA;Cohort 3: Total Serum Clearance (CL) of TEPEZZA;Cohort 3: Estimated Volume of Distribution at Steady State (Vss) of TEPEZZA;Cohort 3: Volume of Distribution During the Terminal Phase (Vz) of TEPEZZA;Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs);Number of Participants Experiencing Serious Adverse Events (SAEs);Number of Participants with Detectable Anti-drug Antibodies (ADA) to TAPEZZA