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BioavailabilityPhase 1NCT06563856

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

A Phase 1 study testing TEPEZZA and EDP in people with Bioavailability and Bioequivalence, run by Amgen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bioavailability, Bioequivalence
What is being tested?
TEPEZZA and EDP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
22 Sep 2020to 27 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.
  • The participant has a history of alcohol abuse or drug addiction within the past 6 months prior to Day 1 dosing.
  • The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at Screening or before receiving the study drug.
  • The participant is involved in strenuous activity or contact sports within 24 hours before receiving the study drug and during the study.
  • The participant has donated blood, had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to Day 1 dosing or received a plasma donation within 7 days prior to Day 1 dosing.
  • The participant has a history of relevant drug and/or food allergies (i.e., allergy or idiosyncratic reaction to components of TEPEZZA or excipients; prior hypersensitivity reactions to mAbs, EDP, or excipients; or any significant food allergy that could preclude a standard diet in the clinical unit).
  • The participant participated in another investigational study within 30 days (or 5 half-lives of the study drug, whichever is longer) prior to dosing on Day 1. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to the date of Day 1 of the current study.
  • The participant has previously participated in a TEPEZZA investigational study or has received TEPEZZA or rHuPH20-containing products.
  • The participant has received a COVID-19 vaccination within 6 weeks before receiving the study drug or during the study.
  • The participant has a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Note: Testing will be performed according to site procedures.
  • The participant is mentally or legally incapacitated or has significant emotional problems at Screening or is expected to have them during the conduct of the study.
  • The participant has a history or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the investigator or designee.
  • The participant had a history of any illness that, in the opinion of the investigator or designee, might confound the results of the study or pose an additional risk to the participant by participation in the study.
  • In the opinion of the investigator or designee, the participant is not suitable for entry into the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Development

    Las Vegas, Nevada, 89113

Other trials in United States

About this study

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

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.

Being tested
TEPEZZA, EDP
Keywords
Thyroid eye disease, Graves' ophthalmopathy, Graves' orbitopathy, Thyroid-associated ophthalmopathy, Immunology
Medical subject headings
Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEPEZZADrug

    Also called HZN-001

    Administered as a SubQ injection or IV injection.

  • EDPDrug

    Administered as a SubQ injection.

Study groups in NCT06563856
Study groupRoleWhat they receive
Cohort 1: TEPEZZA Dose A SubQExperimentalParticipants will receive Dose A of TEPEZZA administered SubQ.
Receives: Drug: TEPEZZA
Cohort 2: TEPEZZA Dose B SubQExperimentalParticipants will receive Dose B of TEPEZZA administered SubQ.
Receives: Drug: TEPEZZA
Cohort 3: TEPEZZA Dose B Intravenously (IV)ExperimentalParticipants will receive Dose B of TEPEZZA administered IV.
Receives: Drug: TEPEZZA
Cohort 4: TEPEZZA Dose B and EDP SubQExperimentalParticipants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ.
Receives: Drug: TEPEZZA; Drug: EDP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

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

    Measured: Day 1 pre-dose to Day 71

Secondary outcomes (14)

  1. Cohort 3: AUCinf of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  2. Cohort 3: AUClast of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  3. Cohort 3: %AUCextrap of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  4. Cohort 3: Cmax of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  5. Cohort 3: Clast of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  6. Cohort 3: Tlast of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  7. Cohort 3: λz of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  8. Cohort 3: t1/2 of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  9. Cohort 3: Total Serum Clearance (CL) of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  10. Cohort 3: Estimated Volume of Distribution at Steady State (Vss) of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  11. Cohort 3: Volume of Distribution During the Terminal Phase (Vz) of TEPEZZA

    Measured: Day 1 pre-dose to Day 71

  12. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Participants will be instructed to contact the investigator at any time after receiving the study drug, if any symptoms develop. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure.

    Measured: Up to approximately Day 71

  13. Number of Participants Experiencing Serious Adverse Events (SAEs)

    An AE is considered an SAE if, in the view of either the investigator or sponsor, it results in any of the following outcomes:

    • Death
    • Life-threatening AE
    • Inpatient hospitalization or prolongation of existing hospitalization
    • Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • Congenital anomaly or birth defect.

    Measured: Up to approximately Day 71

  14. Number of Participants with Detectable Anti-drug Antibodies (ADA) to TAPEZZA

    Measured: Day 1 pre-dose to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start22 Sep 2020
  3. Primary completion27 May 2021
  4. Study completion27 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06563856
Sponsor's protocol ID
HZNP-TEP-102
Status last verified
Aug 2024
First submitted
19 Aug 2024
Last updated
21 Aug 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TEPEZZA and EDP in people with Bioavailability and Bioequivalence, run by Amgen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1, 2, and 4: Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of TEPEZZA (time frame: Day 1 pre-dose to Day 71). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06563856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.

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