NCT05890118

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: RANI Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Stelara	A commercial formulation of ustekinumab for SC control (0.5mg)
COMBINATION_PRODUCT	RT-111 (0.5mg)	RaniPill capsule containing ustekinumab with a dose of 0.5mg
COMBINATION_PRODUCT	RT-111 (0.75mg)	RaniPill capsule containing ustekinumab with a dose of 0.75mg

Timeline

• Start date: 2023-08-30
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2023-06-06
• Last updated: 2024-01-11

Locations

1 site across 1 country: Australia