NCT06555601

A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants

A First-in-Human, Randomized, Investigator-Blind, Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB3101 in Healthy Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	UCB3101	Study participants will receive UCB3101 as prespecified in each cohort.
DRUG	Placebo	Study participants will receive placebo as prespecified in each cohort to maintain the blinding.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-11-24
• Completion: 2025-11-24
• First posted: 2024-08-15
• Last updated: 2025-12-26

Locations

1 site across 1 country: Belgium