Trials / Completed
CompletedNCT06797375
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants
Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Rallybio · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RLYB116 for Injection | RLYB116 is a small protein composed of an Affibody® Z-domain that binds with high affinity to C5, inhibiting terminal complement activation, and an albumin binding domain (ABD) that extends the effective plasma half-life of the protein by targeting serum albumin. |
Timeline
- Start date
- 2025-04-14
- Primary completion
- 2026-02-09
- Completion
- 2026-02-23
- First posted
- 2025-01-28
- Last updated
- 2026-02-27
Locations
1 site across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06797375. Inclusion in this directory is not an endorsement.