|Articles|May 15, 2015

Quotient Clinical Completes Enabled FIH Program

Author(s)Applied Clinical Trials Editorial Staff

Quotient Clinical has announced results from an Enabled-First-in-Human (Enabled-FIH) program conducted for the Janssen WAVE Early Development unit.

Quotient Clinical has announced results from an Enabled-First-in-Human (Enabled-FIH) program conducted for the Janssen WAVE Early Development unit. The integrated pharmaceutical development and first-in-human clinical program was designed to develop an optimal oral formulation, in parallel with the assessment of single and multiple dose safety, pharmacokinetics and pharmacodynamics of a highly selective small molecule c-Met tyrosine kinase inhibitor. The clinical phase, which was conducted under a single, adaptive protocol, was completed in only six months.

Read the full release here.

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

October 1st, 2026

What an AI-Informed Approach Means for How Sponsors Think About Risk

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.

October 1st, 2026

ACT Brief: AI as Design Advisor, Autonomous Agent Governance, Oral Weight-Loss Therapy Switch

In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.

September 30th, 2026

The Control Plane for Agentic Clinical Operations: Governing Autonomous Digital Actors in Regulated Trials

AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.

September 30th, 2026

Where AI Leads in Trial Design—and Where Humans Still Need To

In this video interview, Claire Riches, VP of clinical solutions at Citeline, makes the case for AI as a sophisticated strategic advisor in trial design while arguing that humans must remain in the lead—especially when factors the model can't fully account for are at stake.

September 30th, 2026

ACT Brief: Enrollment Feasibility Pressure-Testing, RWE Infrastructure Gaps, and Peptide Rulemaking Standstill

In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.

© FlowStudio - © FlowStudio - stock.adobe.com

September 29th, 2026

Real-World Evidence Is Moving Upstream: Is the Data Infrastructure Ready?

RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.

September 29th, 2026

The Data Inputs That Matter Most When Pressure-Testing a Protocol's Feasibility

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance data with real-world patient data and site-level recruitment history gives sponsors a far more honest picture of whether their enrollment assumptions are actually achievable.

September 29th, 2026

ACT Brief: Trial Simulations and Protocol Risk, RBQM Financial Value Quantified, and Three Drug Approvals

In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.