Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05890118
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule
Sponsor:
RANI Therapeutics
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: