ArticleEuropean journal of clinical pharmacology2026
Oral delivery of an ustekinumab biosimilar with bioavailability comparable to subcutaneous administration in healthy human participants.
Article in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05890118 (A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of RT-111- RaniPill Capsule Containing Ustekinumab - Administered Orally to Healthy Volunteers
Who cites it
2 citing papers in PubMed.
- Article
- Oral delivery of biologics: from barrier-limited formulation to active convective transport.Frontiers in drug delivery · 2026Review
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeUstekinumab, targeting interleukin (IL)-12 and IL-23, is effective in treating chronic immune-mediated inflammatory diseases, but needs to be dosed via subcutaneous (SC) injection, which impacts patient comfort and treatment adherence. To enable oral dosing of ustekinumab, the utility of a robotic pill (RP) was evaluated in humans.
methodsA Phase 1 study was conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single doses (0.5 and 0.75 mg) of an ustekinumab biosimilar (CT-P43) delivered via RP (RT-111) in healthy participants compared to ustekinumab (0.5 mg) administered via SC injection.
resultsRT-111 was well-tolerated with no reported SAEs. Ustekinumab was detected in 35/40 participants dosed with RT-111. At the 0.5 mg dose, RT-111 and SC administration yielded similar Cmax (RT-111: 67 ± 7 ng/mL, SC: 56 ± 4 ng/mL), while a dose-proportional increase in Cmax was observed at the 0.75 mg dose (92 ± 8 ng/mL). Uptake via oral delivery was faster, with a Tmax of 3 vs. 10 days for the SC group. Bioavailability of RT-111 was comparable (81%) to that of SC injection.
conclusionThis is the first report of successful oral delivery of a therapeutic antibody via an orally ingestible RP in humans, with bioavailability comparable to SC injection. CLINICAL TRIAL NUMBER: Study was registered at Clinicaltrials.gov as NCT05890118 in May 2023.
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