Amgen has terminated a Phase I first-in-human study of AMG 378, an oral small molecule investigational drug, according to a ClinicalTrials.gov update for NCT06910709. The trial, which enrolled healthy volunteers to assess safety, tolerability, and pharmacokinetics across single ascending dose (SAD), multiple ascending dose (MAD), and food-effect cohorts, was discontinued before its planned completion date. No results have been posted to the registry.
The study was a randomized, double-blind, placebo-controlled design enrolling up to 48 adults aged 18 to 55, with a body mass index between 18 and 30 kg/m². Participants were assigned in a 3:1 ratio to AMG 378 or placebo in the SAD and MAD cohorts, while the food-effect cohort used a 1:1 crossover design with a seven-day washout between periods. The primary objective was to quantify treatment-emergent adverse events (TEAEs) through Day 30 for the SAD and MAD groups and Day 40 for the food-effect cohort. Secondary endpoints covered standard pharmacokinetic parameters — Cmax, Tmax, and AUC — under both fasted and fed conditions. The trial was classified as basic science, reflecting its purpose as a first-in-human characterization effort rather than proof-of-concept in a patient population.
The sponsor noted in the registry record that the termination reflected a "business decision", with no safety or efficacy data disclosed. The status was verified as of March 2026, with the last registry update posted shortly thereafter. Whether the decision followed an internal portfolio review, an early safety or tolerability signal, or a pharmacokinetic finding that did not support further development cannot be determined from the available public record.
AMG 378's biological target and mechanism of action have not been disclosed publicly. The drug is formulated as an oral tablet, and the trial record lists no alternate development codes or prior names. The company context provided by pipeline databases classifies the program's global development status as discontinued, consistent with the registry termination. No licensing partners or collaborators were listed for the program.
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