Healthy VolunteersPhase 1NCT05890118
Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule
A Phase 1 study testing Stelara, RT-111 (0.5mg) and RT-111 (0.75mg) in people with Healthy Volunteers, run by RANI Therapeutics at 1 site in Australia.
Trial summary
A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111"). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Stelara, RT-111 (0.5mg) and RT-111 (0.75mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Aug 2023to 28 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 41Show fewer
- 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.
- Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, human immunodeficiency virus (HIV) or history of active, latent, or inadequately treated tuberculosis (TB) infection
- Positive serum pregnancy test for women of childbearing potential at the Screening visit or positive urine pregnancy test with confirmatory serum pregnancy test prior to dosing.
- Females who are breastfeeding.
- Have a history of cancer including lymphoma, leukemia, and skin cancer (volunteers with a maximum of 3 surgically resected basal cell carcinoma or squamous cell carcinoma are permitted).
- Have an illness within 30 days prior to screening, or prior to dosing, that has not resolved and is classed as clinically significant by the Investigator.
- Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] based on a positive COVID-19 polymerase chain reaction [PCR] nasopharyngeal swab test), cough or fever, or a history of recurrent or chronic infections.
- Have had major surgery within 30 days prior to screening or will have an operation between screening and the end of study visit, or have any unhealed wound, including wound dehiscence and wound healing complications requiring medical intervention.
- Have received live vaccines during the past 4 weeks before Screening or have the intention to receive vaccination during the study period or within 13 weeks after dosing.
- Have received a Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to dose administration or is planning to receive a BCG vaccination within 1 year following dose administration.
- History of alcohol abuse (defined as more than 12 standard drinks per week or more than 4 standard drinks on > 3 days per week; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.
- Positive drug or alcohol test results. In the event the urinary drug test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility.
- Donation of more than 500 mL of blood within 4 weeks prior to drug administration.
- Abnormal or irregular bowel movements, in the opinion of the Investigator.
- Any history of non-traumatic hemorrhage (i.e., any hemorrhage requiring medical intervention) or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count < 150,000 per μL) or an international normalized ratio higher than 1.5.
- Impaired liver function as determined by a serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)> 1.5 x upper limit of normal (ULN). Participants with values between ULN and 1.5 x ULN may be included in the study if considered not clinically significant by the Investigator.
- Treatment with non-topical medications (including over-the-counter [OTC] medications and herbal remedies such as St. John's Wort extract) within 7 days or 5 half-lives of the drug (whichever is longer) prior to CTM administration, with the exception of multivitamins, vitamin C, food supplements and a limited amount of acetaminophen (up to 2 g in 24 hours, but <1 g in 4 hours) or ibuprofen (<1.2 g per day), which may be used throughout the study.
- Participants on a higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 9.1.6 for details)
- Participants on a H2 receptor antagonists (e.g., famotidine, cimetidine)
- Consumption of any foods containing poppy seeds within 48 hours prior to screening and admission to the clinical center.
- Presence of proteinuria (other than trace amounts i.e., +, ++/+++).
- Personal history of venous thromboembolic events or idiopathic venous thromboembolic events in a first degree relative.
- Excessive smoking habit (more than 5 cigarettes/day) or drug consumption
- Other clinically relevant findings per physical or laboratory examination or symptoms of a clinically relevant illness 3 weeks prior to the dose of study drug.
- Participation in a clinical study with an IP dosing within 60 days or 5 half-lives of that IP (if known), whichever is longer, prior to IP administration in the current study.
- History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks
- Low likelihood, in the Investigator's judgment, to complete the study as required per study plan
Trial locations and contacts
1 site in 1 country.
About this study
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
A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111").
Read the 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
- Being tested
- Stelara, RT-111 (0.5mg), RT-111 (0.75mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StelaraDrug
A commercial formulation of ustekinumab for SC control (0.5mg)
RT-111 (0.5mg)Combination product
RaniPill capsule containing ustekinumab with a dose of 0.5mg
RT-111 (0.75mg)Combination product
RaniPill capsule containing ustekinumab with a dose of 0.75mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Combination Product: RT-111 (0.75mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 60 days after ingesting the device
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of RT-111)
Monitoring and recording of adverse events possibly related to RT-111.
Measured: Within 60 days after ingesting the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start30 Aug 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- RANI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arvinder Dhalla, PhD, Study director, RANI Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890118
- Sponsor's protocol ID
- RT-111-001
- Status last verified
- Jan 2024
- First submitted
- 25 May 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myers JT, Yamaguchi A, Horlen K, Fung LC, Vo AT, Mohan D, Hoopes M, Imran M, Van Dam J, Gonen OM, Hashim MA, Dhalla AK, Blauvelt A. Oral delivery of an ustekinumab biosimilar with bioavailability comparable to subcutaneous administration in healthy human participants. Eur J Clin Pharmacol. 2026 Jan 19;82(2):40. doi: 10.1007/s00228-025-03969-6.
PubMed 41553505
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05890118
- Acronym / sponsor ID
- RT-111-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- RANI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SC Group | Active comparator | Drug: StelaraIn up to 15 volunteers, 0.5mg of Stelara will be administered subcutaneously and serial blood samples will be collected for PK analysis. |
| RT-111 Group 1 | Experimental | Combination Product: RT-111 (0.5mg)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. |
| RT-111 Group 2 | Experimental | Combination Product: RT-111 (0.75mg)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (41 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StelaraA commercial formulation of ustekinumab for SC control (0.5mg) | Drug | SC Group |
| RT-111 (0.5mg)RaniPill capsule containing ustekinumab with a dose of 0.5mg | Combination product | RT-111 Group 1 |
| RT-111 (0.75mg)RaniPill capsule containing ustekinumab with a dose of 0.75mg | Combination product | RT-111 Group 2 |
Primary outcome
Evaluate Cmax of ustekinumab administered via the RaniPill capsule
Time frame: Within 60 days after ingesting the device
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.
Evaluate Tmax of ustekinumab administered via the RaniPill capsule
Time frame: Within 60 days after ingesting the device
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.
Evaluate AUC of ustekinumab administered via the RaniPill capsule
Time frame: Within 60 days after ingesting the device
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.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of RT-111)
Time frame: Within 60 days after ingesting the device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 41553505Myers JT, Yamaguchi A, Horlen K, Fung LC, Vo AT, Mohan D, Hoopes M, Imran M, Van Dam J, Gonen OM, Hashim MA, Dhalla AK, Blauvelt A. Oral delivery of an ustekinumab biosimilar with bioavailability comparable to subcutaneous administration in healthy human participants. Eur J Clin Pharmacol. 2026 Jan 19;82(2):40. doi: 10.1007/s00228-025-03969-6.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvinder Dhalla, PhD study director
RANI Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stelara, RT-111 (0.5mg) and RT-111 (0.75mg) in people with Healthy Volunteers, run by RANI Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Cmax of ustekinumab administered via the RaniPill capsule (time frame: Within 60 days after ingesting the device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05890118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.