Active — Not RecruitingPhase 1

A Study to Assess the Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chinese Participants

United States32 participantsStarted 2025-04-28

Plain-language summary

The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Male participants must agree to use contraception of the full protocol during the Treatment Period and for 14 days after the final dose of study intervention and refrain from donating sperm during this period.
✓. Female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

Exclusion criteria

✕. aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) \>1.0x upper limit of normal (ULN), (isolated bilirubin \<1.5xULN is acceptable if fractionated and direct bilirubin \<35%).
✕. Tests that result in ALT, AST, bilirubin, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.

What they're measuring

Occurrence of TEAEs (Part A)

Timeframe: From Baseline to the end of Safety Follow-up Period (up to 49 days)

Occurrence of TEAEs (Part B)

Timeframe: From Baseline to the end of Safety Follow-up Period (up to 44 days)

Trial details

NCT IDNCT06970301

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-29

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