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

COMPLETEDPHASE1

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

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

NCT07142642•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participant has provided informed consent.
•2. Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
•3. Male or female participants, between 18 and 60 years of age (inclusive). Female participants must be of nonchildbearing potential.
•4. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
•5. Body mass index between 18 and 27 kg/m\^2 (inclusive) and minimum weight of 55 kg .

Exclusion Criteria

•1. History or evidence of clinically significant disorder, condition, or disease.
•2. 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).
•3. Fasting glucose level (after at least an 8-hour fast) \> 126 mg/dL (\> 7 mmol/L).
•4. History of or ongoing hearing impairment.
•5. History of any autoimmune disease, inflammatory bowel disease, or TED.
•6. History or evidence of ECG-findings.
•7. 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.
•8. History of relevant drug and/or food allergies.
•9. Poor peripheral venous access and/or unable to receive IV infusion therapy.
•10. Estimated glomerular filtration rate less than 90 mL/min/1.73 m2.
+12 more criteria

Locations (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 26, 2025

Primary Completion Date

November 22, 2025

Completion Date

January 15, 2026

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Healthy Volunteers

Interventions

Teprotumumab

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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