Healthy VolunteersPhase 1NCT07142642
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
A Phase 1 study testing Teprotumumab in people with Healthy Volunteers, run by Amgen at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 60 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?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2025to 15 Jan 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant has provided informed consent.
- Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- Male or female participants, between 18 and 60 years of age (inclusive). Female participants must be of nonchildbearing potential.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Body mass index between 18 and 27 kg/m^2 (inclusive) and minimum weight of 55 kg .
Who cannot join
- History or evidence of clinically significant disorder, condition, or disease.
- History of diabetes. (regardless of type with the exception of history of gestational diabetes). Hemoglobin A1C greater than or equal to 6.5% (greater than or equal to 48 mmol/mol).
- Fasting glucose level (after at least an 8-hour fast) > 126 mg/dL (> 7 mmol/L).
- History of or ongoing hearing impairment.
- History of any autoimmune disease, inflammatory bowel disease, or TED.
- History or evidence of ECG-findings.
Show all 22Show fewer
- Systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or < 50 mmHg, or pulse > 100 bpm or < 50 bpm , at screening or check-in.
- History of relevant drug and/or food allergies.
- Poor peripheral venous access and/or unable to receive IV infusion therapy.
- Estimated glomerular filtration rate less than 90 mL/min/1.73 m2.
- Active liver disease or hepatic dysfunction.
- History of a medical condition associated with an increased risk of bleeding.
- History of any major surgery within 6 months.
- History of alcoholism or drug/chemical abuse within 1 year prior to check-in.
- Use of tobacco- or nicotine-containing products within 6 months prior to check-in.
- Positive test for illicit drugs and/or tetrahydrocannabinol/cannabinoids at check-in.
- Female participants with a positive serum pregnancy test.
- Female participants who are lactating/breastfeeding.
- Male participants with partners who are pregnant.
- Unwilling to adhere to contraceptive requirements.
- Participant has received a dose of an investigational drug within the past 90 days.
- Have previously completed or withdrawn from this study or any other study investigating teprotumumab or have previously received the investigational product.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.
- Conditions
- Healthy Volunteers
- Being tested
- Teprotumumab, Placebo
- Keywords
- Pharmacokinetics, Healthy Chinese participants, Thyroid eye disease, TED, Thyroid-associated ophthalmopathy
- 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 Tepezza, AMG 632
Administered via IV infusion.
PlaceboDrug
Administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Teprotumumab | Experimental | Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1. Receives: Drug: Teprotumumab |
| Placebo | Placebo comparator | Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
Measured: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab
Measured: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab
Measured: Up to Day 85
Secondary outcomes (3)
Number of Participants With Treatment-emergent Adverse Events
Measured: Up to Day 85
Number of Participants With Serious Adverse Events
Measured: Up to Day 85
Number of Participants With Anti-teprotumumab Antibodies
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start26 Aug 2025
- Primary completion22 Nov 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142642
- Sponsor's protocol ID
- 20240181
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2025
- Last updated
- 27 Feb 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07142642
- Acronym / sponsor ID
- 20240181
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Healthy Chinese participants, Thyroid eye disease, TED, Thyroid-associated ophthalmopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teprotumumab | Experimental | Drug: TeprotumumabParticipants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant has provided informed consent.
- Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- Male or female participants, between 18 and 60 years of age (inclusive). Female participants must be of nonchildbearing potential.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Body mass index between 18 and 27 kg/m^2 (inclusive) and minimum weight of 55 kg .
Key exclusion criteria (22 listed)
- History or evidence of clinically significant disorder, condition, or disease.
- History of diabetes. (regardless of type with the exception of history of gestational diabetes). Hemoglobin A1C greater than or equal to 6.5% (greater than or equal to 48 mmol/mol).
- Fasting glucose level (after at least an 8-hour fast) > 126 mg/dL (> 7 mmol/L).
- History of or ongoing hearing impairment.
- History of any autoimmune disease, inflammatory bowel disease, or TED.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeprotumumabAlso: Tepezza, AMG 632Administered via IV infusion. | Drug | Teprotumumab |
| PlaceboAdministered via IV infusion. | Drug | Placebo |
Primary outcome
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
Time frame: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab
Time frame: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab
Time frame: Up to Day 85
3 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to Day 85
Number of Participants With Serious Adverse Events
Time frame: Up to Day 85
Number of Participants With Anti-teprotumumab Antibodies
Time frame: Up to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
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 China.
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 5 inclusion and 22 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 27 Feb 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
Maximum Observed Serum Concentration (Cmax) of Teprotumumab (time frame: Up to Day 85). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.