A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

NCT06563856 | Completed Phase 1 FDA Drug

• 1 other identifier: HZNP-TEP-102
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability; Bioequivalence

Keywords

Thyroid eye disease; Graves' ophthalmopathy; Graves' orbitopathy; Thyroid-associated ophthalmopathy; Immunology

Outcome Measures

Primary Outcomes (11)

• Cohort 1, 2, and 4: Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Percentage of the Area Extrapolated for Calculation of AUCinf (%AUCextrap) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Maximum Observed Serum Concentration (Cmax) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Last Quantifiable Serum Concentration (Clast) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Time to Maximum Observed Serum Concentration (Tmax) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Time of Last Quantifiable Serum Concentration (Tlast) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Apparent Terminal Elimination Rate Constant (λz) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Apparent Terminal Half-life (t1/2) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Apparent Serum Clearance (CL/F) of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 1, 2, and 4: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of TEPEZZA

  Day 1 pre-dose to Day 71

Secondary Outcomes (14)

• Cohort 3: AUCinf of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 3: AUClast of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 3: %AUCextrap of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 3: Cmax of TEPEZZA

  Day 1 pre-dose to Day 71

• Cohort 3: Clast of TEPEZZA

  Day 1 pre-dose to Day 71

Study Arms (4)

Cohort 1: TEPEZZA Dose A SubQ

EXPERIMENTAL

Participants will receive Dose A of TEPEZZA administered SubQ.

Drug: TEPEZZA

Cohort 2: TEPEZZA Dose B SubQ

EXPERIMENTAL

Participants will receive Dose B of TEPEZZA administered SubQ.

Drug: TEPEZZA

Cohort 3: TEPEZZA Dose B Intravenously (IV)

EXPERIMENTAL

Participants will receive Dose B of TEPEZZA administered IV.

Drug: TEPEZZA

Cohort 4: TEPEZZA Dose B and EDP SubQ

EXPERIMENTAL

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

Drug: TEPEZZA; Drug: EDP

Interventions

TEPEZZA DRUG

Administered as a SubQ injection or IV injection.

Also known as: HZN-001

Cohort 1: TEPEZZA Dose A SubQ; Cohort 2: TEPEZZA Dose B SubQ; Cohort 3: TEPEZZA Dose B Intravenously (IV); Cohort 4: TEPEZZA Dose B and EDP SubQ

EDP DRUG

Administered as a SubQ injection.

Cohort 4: TEPEZZA Dose B and EDP SubQ

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The participant has a medical condition associated with an increased risk of bleeding - including a history of hematological diseases such as acquired platelet disorders; coagulation disorders - including drug-induced thrombocytopenia, idiopathic thrombocytopenia, or von Willebrand's Disease; or requires the use of antiplatelet or anticoagulant medication.
• Female participants who are lactating or planning to become pregnant from Screening through 180 days after receiving the study drug.
• Male participants who are planning to impregnate a female partner from Day 1 through 180 days after receiving the study drug.
• The participant has consumed alcohol-, caffeine-, or xanthine-containing products within 48 hours before the dose of study drug.
• The participant is a smoker or has used nicotine or nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months before receiving the study drug.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

PPD Development

Las Vegas, Nevada, 89113, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

teprotumumab

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 22, 2020
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (1)