Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RLYB116 · 1 trial · 2 indications
| 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...
RLYB116 is an investigational small molecule being developed for hematologic diseases. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
RLYB116 is being developed by Rallybio Corporation, a biopharmaceutical company. Rallybio's stock trades under the ticker symbol RLYB on the NASDAQ exchange.
RLYB116 is in Phase 1 clinical development. A Phase 1 study of RLYB116 has been completed, and the drug remains investigational. It is not yet approved for any use, and further clinical trials would be needed to establish its safety and efficacy.
RLYB116 has one completed Phase 1 clinical trial, identified as NCT06797375. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of RLYB116 in healthy participants. The trial enrolled 16 participants and was conducted in Australia.
No, RLYB116 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial was a safety and tolerability study in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.