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(RTTNews) - Rani Therapeutics Holdings, Inc. (RANI)On Monday announced positive topline results from its Phase 1 clinical study of RT-111. The study was conducted in Australia and assessed the safety, tolerability, and pharmacokinetics (PK) of RT-111 in healthy adult volunteers.

RT-111 is a RaniPill capsule containing an ustekinumab biosimilar, CT-P43, which is a human IgG1 monoclonal antibody. Currently, ustekinumab is only available as a subcutaneous injection marketed in the United States by Janssen as STELARA. The ustekinumab biosimilar utilized in RT-111 is manufactured and supplied by Celltrion, Inc.

The study included 20 participants in each of the RT-111 0.5mg and 0.75mg dose groups, along with 15 participants in a STELARA (ustekinumab) 0.5mg subcutaneous injection group.

The findings indicate that RT-111 provided ustekinumab biosimilar in a dose-proportional manner with high bioavailability (estimated at 84% relative to subcutaneous injection). It also demonstrated a higher Cmax and shorter Tmax compared to ustekinumab administered via SC injection (0.5mg).

Moreover, all participants in the two RT-111 groups tolerated the treatment well, and no serious adverse events were observed during the study.

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