Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule

NCT05890118 | Completed Phase 1

• 1 other identifier: RT-111-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Evaluate Cmax of ustekinumab administered via the RaniPill capsule

  To obtain PK profiles of single doses of ustekinumab given via RaniPill™ capsule in healthy volunteers over a dose range of 0.5 to 0.75mg. Cmax of ustekinumab will be calculated from the PK profiles.

  Within 60 days after ingesting the device

• Evaluate Tmax of ustekinumab administered via the RaniPill capsule

  To obtain PK profiles of single doses of ustekinumab given via RaniPill™ capsule in healthy volunteers over a dose range of 0.5 to 0.75mg. Cmax of ustekinumab will be calculated from the PK profiles.

  Within 60 days after ingesting the device

• Evaluate AUC of ustekinumab administered via the RaniPill capsule

  To obtain PK profiles of single doses of ustekinumab given via RaniPill™ capsule in healthy volunteers over a dose range of 0.5 to 0.75mg. Cmax of ustekinumab will be calculated from the PK profiles.

  Within 60 days after ingesting the device

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of RT-111)

  Within 60 days after ingesting the device

Study Arms (3)

SC Group

ACTIVE COMPARATOR

In up to 15 volunteers, 0.5mg of Stelara will be administered subcutaneously and serial blood samples will be collected for PK analysis.

Drug: Stelara

RT-111 Group 1

EXPERIMENTAL

In up to 20 volunteers, a RaniPill capsule containing 0.5mg of ustekinumab will be administered and serial blood samples will be collected for PK analysis.

Combination Product: RT-111 (0.5mg)

RT-111 Group 2

EXPERIMENTAL

In up to 20 volunteers, a RaniPill capsule containing 0.75mg of ustekinumab will be administered and serial blood samples will be collected for PK analysis.

Combination Product: RT-111 (0.75mg)

Interventions

Stelara DRUG

A commercial formulation of ustekinumab for SC control (0.5mg)

SC Group

RT-111 (0.5mg) COMBINATION_PRODUCT

RaniPill capsule containing ustekinumab with a dose of 0.5mg

RT-111 Group 1

RT-111 (0.75mg) COMBINATION_PRODUCT

RaniPill capsule containing ustekinumab with a dose of 0.75mg

RT-111 Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is ambulatory and between 18 to 65 years of age
• Body mass index between 19- 32 kg/m2
• RT-111 ONLY: Female volunteers must be non-menstruating at dosing
• Female volunteers must be non-pregnant or non-lactating during study participation
• Male volunteers must agree to use acceptable forms of contraception, if necessary, and to not donate sperm during study participation.
• Have suitable venous access for blood sampling.
• In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per Investigator's judgment
• Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent

You may not qualify if:

• History of intolerance to Stelara® or its constituents
• Have a known history of previous exposure to IL-12 and/or IL-23 inhibitors.
• History (≤10 years) or presence of disease determined by the PI to be clinically significant including:
• gastrointestinal (including diverticulitis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess).
• any other internal, non-gastrointestinal fistulae that is at an increased risk of bleeding.
• hematological (including pancytopenia, aplastic anemia, or blood dyscrasia).
• renal, endocrine, hepatic, pulmonary (childhood asthma is allowed), neurologic, psychiatric, metabolic (including known diabetes mellitus), or
• allergic disease excluding mild asymptomatic seasonal and food allergies.
• Have a history of prolonged immunosuppressant therapy or photochemotherapy treatment.
• Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore or branding that, in the opinion of the Investigator, would interfere with interpretation of skin adverse reactions.
• Have a history of and/or current cardiac disease defined as one of the following:
• History of congestive heart failure; angina pectoris requiring anti-anginal medication.
• Evidence of transmural infarction on ECG.
• History of sustained hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg), hypertensive crisis or hypertension encephalopathy.
• Clinically significant valvular heart disease or severe arterial thromboembolic events.

Sponsors & Collaborators

• RANI Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Arvinder Dhalla, PhD

  RANI Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 6, 2023
• Study Start: August 30, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)