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Healthy VolunteersPhase 1NCT06674941

A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants

A Phase 1 study testing Teprotumumab in people with Healthy Volunteers, 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 trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and to assess the PK of teprotumumab delivered by syringe pump and by an injection device in… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Teprotumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
24 Mar 2023to 14 Nov 2023
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

  • Participant is a healthy male or female between the ages of 18 and 55 years, inclusive, at Screening.
  • Participant has a body mass index between 18 and 30 kg/m^2, inclusive, at Screening.
  • Participant is medically healthy, with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECG results at Screening, as deemed by the Principal Investigator (PI) or designee.
  • If female of childbearing potential (including those with an onset of menopause < 2 years prior to Screening, non-therapy-induced amenorrhea for < 12 months prior to Screening or not surgically sterile [absence of ovaries and/or uterus]) must have a negative serum pregnancy test at Screening and Check-in and negative urine pregnancy tests at all protocol-specified time points (ie, prior to the teprotumumab dose and throughout participation in the Follow-up Period); female participants of childbearing potential who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Day 1 and continue for 180 days after receiving the dose of teprotumumab. Highly effective contraceptive methods (with a failure rate < 1% per year), when used consistently and correctly, include implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner, or sexual abstinence. Abstinence should only be used as a contraceptive method if it is in line with the participant usual and preferred lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not an acceptable method of contraception.
  • If female, participant must agree not to donate an egg/oocyte from Day 1 until 180 days after receiving the dose of teprotumumab.
  • If male, participant must be surgically sterile for at least 6 months prior to dosing or, if sexually active with a female partner of childbearing potential, must agree to use a barrier contraceptive method from Screening through 180 days after receiving the dose of teprotumumab.
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  • If male, must agree not to donate sperm from Day 1 until 180 days after receiving the dose of teprotumumab.
  • Participant has adequate venous access.
  • Participant understands the trial procedures in the ICF and is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
  • Additional Inclusion Criteria for Cohort 2:
  • First generation Japanese healthy male or female participants must meet all of the following as confirmed by interview:
  • Descendants of 4 ethnic Japanese grandparents who were born in Japan
  • Both parents are ethnic Japanese who were born in Japan
  • Hold a Japanese passport or identity papers
  • Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan.

Who cannot join

  • Participant has a history or presence of a clinically significant medical or psychiatric condition or disease, in the opinion of the PI or designee.
  • Participant has a history of any illness that, in the opinion of the PI or designee, might confound the results of the trial or pose an additional risk to the participant due to participation in the trial.
  • Participant has a history or presence of alcoholism (defined as > 10 standard drinks per week, where 1 standard drink = 284 mL of full-strength [4.9% alc/vol] beer, 30 mL of 40% [alc/vol] spirit or a 100 mL glass of wine]) or drug abuse within the 6 months prior to Day 1 dosing.
  • Participant has a history or presence of hypersensitivity or idiosyncratic reaction to components of teprotumumab or prior hypersensitivity reactions to a monoclonal antibody or history.
  • Participant has a history or presence of:
  • thyroid eye disease
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  • diagnosis of autoimmune diseases
  • inflammatory bowel disease
  • Participant has an alanine transaminase or aspartate transaminase level > 1.5 times upper limit of normal at Screening or Check-in.
  • Participant has glycated hemoglobin ≥ 6.5% and/or fasting glucose level (after at least an 8-hour fast) > 126 mg/dL at Screening.
  • Participant has clinically significant abnormal ECG measurements at Screening or prior to teprotumumab dosing, in the opinion of the PI, or has second- or third-degree atrioventricular block or any of the following:
  • QRS > 120 msec
  • QTcF) > 450 msec (males) or > 470 msec (females)
  • PR interval > 220 msec
  • Participant has a medical condition associated with increased risk of bleeding, including history of hematological diseases such as acquired platelet disorders and coagulation disorders, including drug-induced thrombocytopenia, idiopathic thrombocytopenia or von t medication.
  • Participant has donated blood, has had significant blood loss, or has received a transfusion of any blood or blood products within 60 days prior to Day 1 or plasma donation within 7 days prior to Day 1.
  • Participant has participated in another clinical trial within 30 days (or 5 half-lives of the trial drug, whichever is longer) prior to Day 1. The 30-day (or 5 half-lives) window will be derived from the date of last dosing in the previous trial to the date of Day 1 of the current trial.
  • Participant has previous participation in a teprotumumab clinical trial or received teprotumumab or any anti-human insulin-like growth factor-1 receptor monoclonal antibody.
  • Participant has any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial.
  • Participant has used any prescription (excluding hormonal birth control) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before receiving the study drug. Over-the-counter use of acetaminophen (up to 2 g per day), topical eye drops, and topical creams are allowed. Use of other over-the-counter medications may be allowed at the discretion of Investigator with approval from the Medical Monitor.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Development, LP

    Las Vegas, Nevada, 89113-2237

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Single-dose Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Volunteers

The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and to assess the PK of teprotumumab delivered by syringe pump and by an injection device in non-Japanese participants.

Being tested
Teprotumumab
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.

  • TeprotumumabDrug

    Also called Teprotumumab-trbw, TEPEZZA, HZN-001

    Administered as an SC injection.

Study groups in NCT06674941
Study groupRoleWhat they receive
Cohort 1: TeprotumumabExperimentalNon-Japanese participants will receive SC injection of teprotumumab Dose A by a syringe pump.
Receives: Drug: Teprotumumab
Cohort 2: TeprotumumabExperimentalJapanese participants will receive SC injection of teprotumumab Dose A by a syringe pump.
Receives: Drug: Teprotumumab
Cohort 3: TeprotumumabExperimentalNon-Japanese participants will receive SC injection of teprotumumab Dose B by an injection device.
Receives: Drug: Teprotumumab

What is being measured

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

  1. Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of Teprotumumab

    Measured: Day 1 pre-dose to Day 57

  2. AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Teprotumumab

    Measured: Day 1 pre-dose to Day 57

  3. Maximum Observed Serum Concentration (Cmax) of Teprotumumab

    Measured: Day 1 pre-dose to Day 57

  4. Time to Cmax (Tmax) of Teprotumumab

    Measured: Day 1 pre-dose to Day 57

Secondary outcomes (3)

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

    Number of participants with TEAEs, severe TEAEs, infusion-related reactions, injection-site reactions, and adverse device effects will be reported. Clinically significant changes in laboratory tests, vital signs and electrocardiograms (ECG) will be reported as adverse events.

    Measured: Up to Day 57

  2. Number of Participants with Anti-drug Antibodies (ADA) to Teprotumumab

    Measured: Day 1 pre-dose to Day 57

  3. Titer of Positive ADA to Teprotumumab

    Measured: Day 1 pre-dose to Day 57

Timeline

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

  1. First posted5 Nov 2024
  2. Study start24 Mar 2023
  3. Primary completion14 Nov 2023
  4. Study completion14 Nov 2023

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674941
Sponsor's protocol ID
HZNP-TEP-104
Status last verified
Nov 2024
First submitted
4 Nov 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
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 Teprotumumab in people with Healthy Volunteers, 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 15 inclusion and 20 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 5 Nov 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?

Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of Teprotumumab (time frame: Day 1 pre-dose to Day 57). The study lists 4 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 NCT06674941.

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 5 Nov 2024.

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