A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

NCT07142642 | Completed Phase 1 FDA Drug

• 1 other identifier: 20240181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Healthy Chinese participants; Thyroid eye disease; TED; Thyroid-associated ophthalmopathy

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Serum Concentration (Cmax) of Teprotumumab

  Up to Day 85

• Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab

  Up to Day 85

• Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab

  Up to Day 85

Secondary Outcomes (3)

• Number of Participants With Treatment-emergent Adverse Events

  Up to Day 85

• Number of Participants With Serious Adverse Events

  Up to Day 85

• Number of Participants With Anti-teprotumumab Antibodies

  Up to Day 85

Study Arms (2)

Teprotumumab

EXPERIMENTAL

Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1.

Drug: Teprotumumab

Placebo

PLACEBO COMPARATOR

Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1.

Drug: Placebo

Interventions

Teprotumumab DRUG

Administered via IV infusion.

Also known as: Tepezza, AMG 632

Teprotumumab

Placebo DRUG

Administered via IV infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: August 27, 2025
• Study Start: August 26, 2025
• Primary Completion: November 22, 2025
• Study Completion: January 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

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

CN (1)