Rani Therapeutics Initiates P-I Study of RT-111 (biosimilar, ustekinumab) for Autoimmune Diseases
- The company initiates the P-I trial to evaluate RT-111, an orally administered RaniPill GO capsule containing an ustekinumab biosimilar CT-P43 in ~55 healthy human patients. The trial will consist of 3 cohorts with 2 cohorts evaluating RT-111 at a dose of 0.5 or 0.75mg, administered as a RaniPill capsule containing ustekinumab & third cohort will receive Stelara (0.5mg, SC)
- The trial focuses on evaluating the PK, safety & tolerability of RT-111. The results are expected early in Q1’24
- Ustekinumab, a human IgG1қ mAb that binds with specificity to the p40 protein subunit & is marketed in the US as Stelara. Rani & Celltrion collaborated on Jan 2023 for the development of RT-111 (biosimilar, ustekinumab)
Ref: Rani Therapeutics | Image: Rani Therapeutics
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