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A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522534-31-00
Acronym
PB016-01-02
Enrollment
132
Registered
2025-11-13
Start date
2026-01-27
Completion date
Unknown
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers, Not applicable

Interventions

None listed

Sponsors

Polpharma Biologics S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026