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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-26

Study Completion Date

2026-01-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Teprotumumab

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

Group Type EXPERIMENTAL

Teprotumumab

Intervention Type DRUG

Administered via IV infusion.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered via IV infusion.

Interventions

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Teprotumumab

Administered via IV infusion.

Intervention Type DRUG

Placebo

Administered via IV infusion.

Intervention Type DRUG

Other Intervention Names

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Tepezza AMG 632

Eligibility Criteria

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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.
11. Active liver disease or hepatic dysfunction.
12. History of a medical condition associated with an increased risk of bleeding.
13. History of any major surgery within 6 months.
14. History of alcoholism or drug/chemical abuse within 1 year prior to check-in.
15. Use of tobacco- or nicotine-containing products within 6 months prior to check-in.
16. Positive test for illicit drugs and/or tetrahydrocannabinol/cannabinoids at check-in.
17. Female participants with a positive serum pregnancy test.
18. Female participants who are lactating/breastfeeding.
19. Male participants with partners who are pregnant.
20. Unwilling to adhere to contraceptive requirements.
21. Participant has received a dose of an investigational drug within the past 90 days.
22. Have previously completed or withdrawn from this study or any other study investigating teprotumumab or have previously received the investigational product.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes