NCT04444466

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants

A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.

Detailed description

The Study was only open for recruitment of Healthy Study Participants (Part A) prior to termination and did not enroll any patient population.

Conditions

• Healthy Study Participants
• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	UCB8600	Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period.
OTHER	Placebo	Study participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600.

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-08-02
• Completion: 2021-08-02
• First posted: 2020-06-23
• Last updated: 2022-07-19

Locations

1 site across 1 country: Bulgaria