WHO ICTRP trial

Study to evaluate the safety, tolerability, and effect of the body and food on…

ISRCTN63295298 · International Standard Randomised Controlled Trial Number (ISRCTN) · Recruiting

Key facts

Trial ID ISRCTN63295298
Public title Study to evaluate the safety, tolerability, and effect of the body and food on RO7308480 following oral administration in healthy participants
Scientific title A Phase I randomized, investigator/participant-blind, adaptive, single ascending dose, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and food effects of RO7308480 following oral administration in healthy participants
Primary sponsor F. Hoffmann-La Roche Ltd
Registry International Standard Randomised Controlled Trial Number (ISRCTN)
Recruitment status Recruiting
Study type Interventional
Phase Phase I
Countries France
Conditions Safety, tolerability, pharmacokinetics, and food effects of single-ascending oral doses of RO7308480 in healthy participants Not Applicable
Interventions Part 1: RO7308480-SAD Cohorts: Participants will receive a single dose of RO7308480 capsule, orally, under fasted conditions on Day 1 in cohort 1. The dose will be escalated in subsequent cohorts in six steps as per the Sponsor’s clinical…
Registration date Nov 2, 2022
Target size 96
Secondary IDs 2021-004128-13;Nil known;BP43318
Registry page isrctn.com

At a glance

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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