drugset / Trial / NCT06797375

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants

NCT06797375 ↗

Phase 1 Completed 16 enrolled Rallybio
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.

Timeline

Start
2025-04-14
Primary completion
2026-02-09
Completion
2026-02-23

Outcome

Met primary endpoint

release “A 300 mg once-a-week dose of subcutaneously administered RLYB116 achieved complete and sustained inhibition of terminal complement.” affibody.se ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject RLYB116 Protein / enzyme biologic — —