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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05890118




Registration number
NCT05890118
Ethics application status
Date submitted
25/05/2023
Date registered
6/06/2023
Date last updated
11/01/2024

Titles & IDs
Public title
Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule
Scientific 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
Secondary ID [1] 0 0
RT-111-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Stelara
Combination Product - RT-111 (0.5mg)
Combination Product - RT-111 (0.75mg)

Active Comparator: SC Group - In up to 15 volunteers, 0.5mg of Stelara will be administered subcutaneously and serial blood samples will be collected for PK analysis.

Experimental: RT-111 Group 1 - 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.

Experimental: RT-111 Group 2 - 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.


Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate Cmax of ustekinumab administered via the RaniPill capsule
Timepoint [1] 0 0
Within 60 days after ingesting the device
Primary outcome [2] 0 0
Evaluate Tmax of ustekinumab administered via the RaniPill capsule
Timepoint [2] 0 0
Within 60 days after ingesting the device
Primary outcome [3] 0 0
Evaluate AUC of ustekinumab administered via the RaniPill capsule
Timepoint [3] 0 0
Within 60 days after ingesting the device
Secondary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of RT-111)
Timepoint [1] 0 0
Within 60 days after ingesting the device

Eligibility
Key inclusion criteria
1. Participant is ambulatory and between 18 to 65 years of age

2. Body mass index between 19- 32 kg/m2

3. RT-111 ONLY: Female volunteers must be non-menstruating at dosing

4. Female volunteers must be non-pregnant or non-lactating during study participation

5. Male volunteers must agree to use acceptable forms of contraception, if necessary, and
to not donate sperm during study participation.

6. Have suitable venous access for blood sampling.

7. In good general health confirmed by medical history, physical examination, and absence
of clinically important laboratory abnormalities per Investigator's judgment

8. Participant understands the nature of the study, is willing to comply with protocol
defined evaluations, and provide written informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of intolerance to Stelara® or its constituents

2. Have a known history of previous exposure to IL-12 and/or IL-23 inhibitors.

3. History (=10 years) or presence of disease determined by the PI to be clinically
significant including:

1. gastrointestinal (including diverticulitis, stomach ulcers, inflammatory
intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal
abscess).

2. any other internal, non-gastrointestinal fistulae that is at an increased risk of
bleeding.

3. hematological (including pancytopenia, aplastic anemia, or blood dyscrasia).

4. renal, endocrine, hepatic, pulmonary (childhood asthma is allowed), neurologic,
psychiatric, metabolic (including known diabetes mellitus), or

5. allergic disease excluding mild asymptomatic seasonal and food allergies.

4. Have a history of prolonged immunosuppressant therapy or photochemotherapy treatment.

5. 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.

6. Have a history of and/or current cardiac disease defined as one of the following:

1. History of congestive heart failure; angina pectoris requiring anti-anginal
medication.

2. Evidence of transmural infarction on ECG.

3. History of sustained hypertension (systolic > 180 mmHg and/or diastolic > 100
mmHg), hypertensive crisis or hypertension encephalopathy.

4. Clinically significant valvular heart disease or severe arterial thromboembolic
events.

7. 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

8. 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.

9. Females who are breastfeeding.

10. 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).

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. Donation of more than 500 mL of blood within 4 weeks prior to drug administration.

19. Abnormal or irregular bowel movements, in the opinion of the Investigator.

20. 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.

21. 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.

22. 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.

23. Participants on a higher than the lowest approved therapeutic dose regimen of proton
pump inhibitors (see Section 9.1.6 for details)

24. Participants on a H2 receptor antagonists (e.g., famotidine, cimetidine)

25. Consumption of any foods containing poppy seeds within 48 hours prior to screening and
admission to the clinical center.

26. Presence of proteinuria (other than trace amounts i.e., +, ++/+++).

27. Personal history of venous thromboembolic events or idiopathic venous thromboembolic
events in a first degree relative.

28. Excessive smoking habit (more than 5 cigarettes/day) or drug consumption

29. 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.

30. 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.

31. History which, in the investigator's judgement, makes the participant ineligible or
exposes the participant to unacceptable risks

32. Low likelihood, in the Investigator's judgment, to complete the study as required per
study plan

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2023
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RANI Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK)
of ustekinumab administered via the RaniPill™ capsule ("RT-111").
Trial website
https://clinicaltrials.gov/ct2/show/NCT05890118
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arvinder Dhalla, PhD
Address 0 0
RANI Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries