Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule
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)
official title
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of RT-111- RaniPill Capsule Containing Ustekinumab - Administered Orally to Healthy Volunteers