U.S. biopharmaceutical company Rani Therapeutics has embarked on a phase 1 clinical trial of oral ustekinumab (RT-111) using Celltrion's Stellara biosimilar CT-P43.

In January, Celltrion agreed with Rani to develop oral ustekinumab and adalimumab (Humira). Celltrion will develop its antibodies as oral medicines using Rani's oral capsule platform, Ranipil.

According to Celltrion, oral capsules made with Raniphil technology disintegrate in the small intestine, and the drug is delivered to the small intestine through dissolvable micro-needles in the capsule, which are then transported to the bloodstream. The oral capsules are designed to deliver the drug via micro-needles, similar to injections.

Rani Therapeutics will evaluate the pharmacokinetics and safety of RT-111 in up to 55 healthy participants in the phase 1 study. Top-line results from the phase 1 study are expected early in the first quarter of next year. Celltrion has the right to negotiate a global development and commercialization license.

"We are pleased to announce the initiation of clinical trials of RT-111, which brings us one step closer to our goal of developing an oral treatment for patients with autoimmune diseases,” Rani Therapeutics CEO Talat Imran said.

A Celltrion official said, "We believe that Rani's drug delivery platform has the potential to be applied more broadly to our product pipeline, and we will be monitoring the clinical results to consider expanding our collaboration."