A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TEPEZZA Subcutaneous Administration in Healthy Adult Subjects

Amgen1 site in 1 country37 target enrollmentSeptember 22, 2020

ConditionsBioavailability Bioequivalence

InterventionsTEPEZZA EDP

DrugsTEPEZZA EDP

Overview

Phase: Phase 1
Intervention: TEPEZZA
Conditions: Bioavailability
Sponsor: Amgen
Enrollment: 37
Locations: 1
Primary Endpoint: Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.

Registry

clinicaltrials.gov

Start Date

September 22, 2020

End Date

May 27, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participant is able to provide written informed consent.
•The participant is male or female 18 to 55 years of age, inclusive.
•The participant has a body mass index (BMI) between 21 to 30 kg/m\^², inclusive, and a minimum weight of 55 kg at Screening.
•The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening.
•The participant has adequate venous access and can receive IV therapy.
•Female participants of childbearing potential must have a negative serum pregnancy test at Screening and Check-in and negative urine pregnancy tests at all other protocol-specified time points. Participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the study, one of which is recommended to be hormonal, such as an oral contraceptive.
•Female participants must agree not to donate an egg/oocyte from Day 1 until 180 days after receiving the study drug.
•Male participants must agree not to donate sperm from Day 1 until 180 days after receiving the study drug.
•The participant is willing and able to comply with all protocol requirements and evaluations for the duration of the study.

Exclusion Criteria

•The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at Screening.
•The participant has a diagnosis of an autoimmune disease; or a history of HIV, hepatitis B virus (HBV), or HCV infection; a history of inflammatory bowel disease (IBD), or a history of or active thyroid eye disease (TED) at Screening.
•The participant has active liver disease or hepatic dysfunction at Screening or Check-in, as determined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>1.5 times upper limit of normal (ULN).
•The participant has glycated hemoglobin (HbA1c) levels ≥8% and/or fasting glucose levels (after at least an 8-hour fast) \>126 mg/dL (\>7 mmol/L) at Screening.
•The participant has a seated resting blood pressure of \<90/40 mmHg or \>140/90 mmHg, or a seated pulse rate of \<40 beats per minute (bpm) or \>99 bpm or is considered clinically significant at Screening. One additional measurement can be taken if blood pressure and pulse rate are outside the specified limits.
•The participant has clinically significant 12-lead ECG abnormalities at Screening and Check-in or, in the opinion of the investigator, has a second- or third-degree atrioventricular (AV) block, or has any of the following:
•QRS \>120 msec
•QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 msec (males) or \>470 msec (females)
•PR interval \>220 msec
•The participant has used any prescription (excluding hormonal birth control) or over-the-counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before receiving the study drug.

Arms & Interventions

Cohort 1: TEPEZZA Dose A SubQ

Participants will receive Dose A of TEPEZZA administered SubQ.

Intervention: TEPEZZA

Cohort 2: TEPEZZA Dose B SubQ

Participants will receive Dose B of TEPEZZA administered SubQ.

Intervention: TEPEZZA

Cohort 3: TEPEZZA Dose B Intravenously (IV)

Participants will receive Dose B of TEPEZZA administered IV.

Intervention: TEPEZZA

Cohort 4: TEPEZZA Dose B and EDP SubQ

Participants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ.

Intervention: TEPEZZA

Cohort 4: TEPEZZA Dose B and EDP SubQ

Participants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ.

Intervention: EDP