Amgen Advances Teprotumumab Program With Completed Phase 1 Study in Healthy Chinese Volunteers

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

Study Overview

Amgen has completed a Phase 1 study (NCT07142642) titled “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.” The goal was to see how the drug moves through the body, and how safe and tolerable it is, after a single dose in healthy Chinese adults. This work matters because it helps Amgen understand whether an existing biologic can be used reliably in a key regional market, an important step before wider development or label expansion.

Intervention/Treatment

The study tested teprotumumab, also known as Tepezza or AMG 632. It is an infused antibody drug given through a vein. The trial compared a single dose of teprotumumab to an inactive placebo infusion. The aim was to confirm if the dosing used elsewhere is suitable and safe for Chinese participants and to check for any differences in drug exposure.

Study Design

This was an interventional, early-stage trial. Participants were randomly assigned to receive either teprotumumab or placebo in a 3:1 ratio. It used a parallel group design, meaning each participant received only one of the treatments. The study was double-blind: neither volunteers nor doctors knew who got the drug or placebo. The main goal was basic science, focused on measuring drug levels over time and tracking side effects, rather than testing long-term clinical benefit.

Study Timeline

The study was first submitted on August 25, 2025, marking the formal start of the regulatory record and planning phase. The overall trial status is listed as completed, indicating dosing and key follow-up are finished. While the database does not yet show a separate primary completion date or posted results, the record was last updated on January 26, 2026. This latest update signals that Amgen has refreshed key information and that internal analysis of the data is likely well advanced.

Market Implications

For investors, this update reinforces Amgen’s push to unlock more value from its antibody portfolio in international markets, including China. A clean safety and drug-exposure profile in healthy Chinese participants would reduce regulatory risk for future local trials and potential launches. Although Phase 1 studies rarely move stocks on their own, they support the long-term case for geographic expansion and may slightly strengthen sentiment around Amgen’s pipeline execution. In the wider biotech space, companies developing similar biologics for immune and eye-related conditions are also working to localize data for China, so this step keeps Amgen competitive. Any meaningful impact on valuation would likely depend on later-stage studies showing strong efficacy in target diseases, but this completed trial is a necessary building block for that path.

The study record is completed and recently updated, with further details available on the ClinicalTrials portal.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.