Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT05890118
Brief Summary:
A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111").
Detailed Description:
The RaniPill device is a capsule-like ingestible device, which injects a microneedle containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center, prospective, open-label, phase 1 study.
Healthy Volunteers, 18-65 years of age, of any race, recruited from the general population and assigned to one of the following groups:
* Group 1 (SC Control): Stelara®, 0.5mg via SC injection (N= up to 15)
* Group 2: RT-111-0.50 mg (N= up to 20)
* Group 3: RT-111-0.75 mg (N=up to 20)
Study:
NCT05890118
Study Brief:
Protocol Section:
NCT05890118