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Also known as RLYB116 for Injection
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 by Rallybio Corporation for hematologic diseases. It is also known as RLYB116 for Injection. It is designed to act on the complement system, a part of the immune system involved in blood and autoimmune disorders, and it is currently in Phase 1 clinical development.
RLYB116 targets C5, a complement protein. C5 sits within the complement cascade, the immune signaling pathway that drives certain hematologic and autoimmune conditions. By binding C5, RLYB116 is intended to modulate complement activity. It is a small molecule rather than an antibody-based complement inhibitor.
Rallybio Corporation develops RLYB116. Rallybio is a clinical-stage biotechnology company traded on the Nasdaq under the ticker RLYB. The company is the sponsor of the RLYB116 clinical program, including the Phase 1 study conducted in healthy participants.
RLYB116 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has completed one trial, a safety, tolerability, pharmacokinetics and pharmacodynamics study in healthy participants, and no trials are currently listed as active.
RLYB116 has been studied in one completed Phase 1 trial, NCT06797375, titled a Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants. The trial enrolled 16 participants in Australia, was randomized, double-blind and placebo-controlled, and included healthy volunteers aged 18 years and older.
Yes. RLYB116 for Injection is an alternative name for RLYB116, the investigational small molecule developed by Rallybio Corporation. Both names refer to the same C5-targeting compound being evaluated in hematologic diseases, so searches for either name point to the same drug asset and clinical program.