MedTrace Logo

Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule

NCT05890118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-01-11

No results posted yet for this study

Summary

A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111").

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • RANI Therapeutics

    lead INDUSTRY

Principal Investigators

  • Arvinder Dhalla, PhD · RANI Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2023-11-28
Completion
2023-11-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05890118 on ClinicalTrials.gov