A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
Not Applicable
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Placebo
- Registration Number
- NCT07142642
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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 .
Exclusion Criteria
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teprotumumab Teprotumumab Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1. Placebo Placebo Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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