Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06797375 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants | PHASE1 | COMPLETED | 16 | — | — | Apr 14, 2025 | Feb 23, 2026 | Feb 27, 2026 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| RLYB116 Dose 1 | EXPERIMENTAL | RLYB116 for Injection Dose 1, weekly for 5 weeks |
| RLYB116 Dose 2 | EXPERIMENTAL | RLYB116 for Injection Dose 2, weekly for 5 weeks |
| Placebo for Injection | PLACEBO_COMPARATOR | Sodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks |
| Name | Type | Description |
|---|---|---|
| RLYB116 for Injection | DRUG | 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. |
Inclusion Criteria: 1. Male and female participants, 18 to 55 years of age. 2. Able to provide written informed consent. 3. Body mass index (BMI) of 18.0 to 32.0 kg/m2. 4. Must have been vaccinated against N. meningitidis and S. pneumoniae with approved vaccine according to product label. All parti...