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

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Teprotumumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07142642

20240181

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Teprotumumab

Experimental group

Description:

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

Treatment:

Drug: Teprotumumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo