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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/NCT06045624




Registration number
NCT06045624
Ethics application status
Date submitted
13/09/2023
Date registered
21/09/2023
Date last updated
5/04/2024

Titles & IDs
Public title
A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects
Scientific title
A Phase 1, First in Human, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Open Label Food Effect Study to Evaluate Safety, Tolerability, and Pharmacokinetics of OR-101 Administered Orally in Healthy Subjects
Secondary ID [1] 0 0
OR101-HS101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OR-101 (Single ascending dose)
Treatment: Drugs - OR-101 (Food effect)
Treatment: Drugs - OR-101 (Multiple ascending dose)
Treatment: Drugs - Placebo

Experimental: Part A - Drug- OR-101
Dosage level: SAD participants will receive either placebo or one of planned doses levels of 15mg, 45mg, 150mg, 450mg, 900mg, 1500mg OR-101 in dose escalating manner in cohorts 1-6.
Dosage form: Solution
Route of administration- Oral

Experimental: Part B - Drug- OR101
Dosage level: Food effect participants (8 subjects in 9 cohorts) will only receive OR-101with a high fat meal prior to administration and subjects in corresponding dose under fasted condition will serve as their reference group.
Dosage form: Solution
Route of administration- Oral

Experimental: Part C - Drug- OR-101
Dosage level: MAD participants will receive either placebo or one of planned doses levels of 15mg, 45mg, 135mg, 270mg, 540mg and 900mg OR-101 in dose escalating manner in cohorts 1-6. Total dosage of cohort 7 and 8 will be decided based on Safety review committe's input where cohort 8 will receive this daily for 7 days.
Dosage form: Solution
Route of administration- Oral

Placebo Comparator: Placebo - Placebo comparators taken by participants randomised to the placebo arm across Part A and C of the study.


Treatment: Drugs: OR-101 (Single ascending dose)
SAD participants will receive either placebo or one of planned doses levels of 15mg, 45mg, 150mg, 450mg, 900mg, 1500mg OR-101 in dose escalating manner in cohorts 1-6.

Treatment: Drugs: OR-101 (Food effect)
Food effect participants (8 subjects in 9 cohorts) will only receive OR-101with a high fat meal prior to administration and subjects in corresponding dose under fasted condition will serve as their reference group

Treatment: Drugs: OR-101 (Multiple ascending dose)
MAD participants will receive either placebo or one of planned doses levels of 15mg, 45mg, 135mg, 270mg, 540mg and 900mg OR-101 in dose escalating manner in cohorts 1-6. Total dosage of cohort 7 and 8 will be decided based on Safety review committe's input where cohort 8 will receive this daily for 7 days

Treatment: Drugs: Placebo
Participants will receive matching placebo across Part A and C of the study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Treatment emergent Adverse events (TEAEs)
Timepoint [1] 0 0
Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Primary outcome [2] 0 0
Number of participants with Serious Adverse events (SAEs)
Timepoint [2] 0 0
Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Primary outcome [3] 0 0
Number of participants with changes in 12-lead ECG findings
Timepoint [3] 0 0
Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Primary outcome [4] 0 0
Number of participants in clinical laboratory tests
Timepoint [4] 0 0
Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Secondary outcome [1] 0 0
PK Parameters: Maximum Concentration (Cmax)
Timepoint [1] 0 0
SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
Secondary outcome [2] 0 0
PK Parameters: Tmax
Timepoint [2] 0 0
SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
Secondary outcome [3] 0 0
PK Parameters: Area under the curve (AUC)
Timepoint [3] 0 0
SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
Secondary outcome [4] 0 0
PK Parameters: half life (t1/2)
Timepoint [4] 0 0
SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
Secondary outcome [5] 0 0
Urine PK Parameters: Renal Clearance (CLr)
Timepoint [5] 0 0
SAD Phase only: Urine PK samples at predose void on Day 1, and at 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-60, 60-72 hours postdose.
Secondary outcome [6] 0 0
Urine PK Parameters: nonrenal Clearance (CLnr)
Timepoint [6] 0 0
SAD Phase only: Urine PK samples at predose void on Day 1, and at 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-60, 60-72 hours postdose.

Eligibility
Key inclusion criteria
1. Is willing to sign and date IRB-approved ICF.

2. Is a man or woman between the ages of 18 and 55, inclusive.

3. Has a BMI of 18.0 to 30.5 kg/m2 and a total body weight >50 kg for a man and >45 kg
for a woman at Screening and Check-in of Day -1.

4. Is in good health as determined by medical history, PE, clinical laboratory studies,
ECGs, VS, and Investigator's judgement (repeat tests are allowed at PI's discretion).

5. Is willing to minimize sun exposure, avoid phototherapy, and not to use tanning beds,
tanning booths, or sun lamps during the study (Day 1 to EOS).

6. If a woman of childbearing potential, must not be pregnant, lactating, or planning to
become pregnant during the study.

7. Willing to follow the methods of contraception as per the protocol.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has any condition that precludes a subject's ability to comply with study
requirements, including completion of the study visits.

2. Has a history or current evidence of a clinically significant cardiovascular,
respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic,
genitourinary, dermatological, psychiatric or neurologic abnormality or disease or
other medical disorder, including cancer or malignancies.

3. Has clinically significant abnormal laboratory test values as determined by the
Investigator or the local or Sponsor Medical Monitor.

4. has BP and HR measurement after 5 minutes rest in a supine position of:

- systolic BP >150 or <90 mmHg

- diastolic BP of >95 or <45 mmHg

- HR >100 or <50 bpm

- 2 repeats of the subject's BP or HR are permitted for eligibility purposes

5. Has a history of, or currently has, any clinically significant ECG finding, or a QT
interval corrected by Fridericia's method (QTcF) of > 450 msec for males and > 470
msec for females.

6. Has unacceptable COVID-19 test results (if required per site policy at the time of
enrollment).

7. Has a history of HIV, or hepatitis B or C, or positive serology. Note: Subjects with a
history of hepatitis C who have been treated and cured (no detectable HCV RNA) are
allowed.

8. Has a history of tuberculosis.

9. Has an active immune suppressed condition or disease.

10. Has a history of recurrent HSV infections (HSV 1 and/or 2) requiring chronic antiviral
suppressive therapies (defined as greater than 4 episodes or breakout per calendar
year).

11. Is unable to swallow study drug or has a known intolerance or hypersensitivity to
OR-101 or any of the excipients contained in the study drug.

12. Has participated in a clinical study and received active treatment during the last 30
days or 5 half-lives, whichever is longer, prior to Day 1.

13. Has received any prescription medication within the last 14 days prior to Day 1 or
nonprescription OTC medication within the last 7 days prior to Day 1, or supplement
(e.g., St John's wort, echinacea, kava kava, and common valerian) that may
induce/inhibit CYP isozymes within the last 30 days or 5 half-lives, whichever is
longer, prior to Day 1.

Note: acetaminophen (paracetamol) or ibuprofen are permitted medications on an as
needed basis.

14. Has recent history (within 6 months of screening) of alcohol or drug abuse.

15. Consumes more than 14 units of alcohol per week (7 days) for at last 30 days prior to
Day 1 and throughout the end of the study or those who have a history of alcohol or
drug/chemical abuse Note: 1 unit of alcohol is equivalent to 240 mL of beer, 120 mL of
wine, or 30 mL of spirits.

16. Consumes greater than 500 mg of caffeine or xanthine-containing products per day
(e.g., approximately five 240-mL cups of coffee, ten 240-mL cups of tea, twelve 360-mL
cans of soft drinks, energy drinks) for at last 30 days prior to Day 1 and throughout
the end of the study.

17. Is an active smoker and/or has used nicotine or nicotine-containing products (e.g.,
nicotine patch and electronic cigarette) within 3 months of Day 1 (to be confirmed by
carbon monoxide breath test).

18. Refuses to abstain from alcohol, grapefruit, or Seville-orange containing foods (e.g.,
orange marmalade) or beverages, from 48 hours prior to Day 1 through the end of the
study.

19. Has donated blood > 500 mL within 60 days prior to the Screening Visit (Plasma
donation is allowed).

20. Is an employee of Ornovi Pty Ltd or the CRO, or has an immediate family member who is
an employee of Ornovi Pty Ltd or the CRO.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/02/2024
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
SCIENTIA Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ornovi, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This first in human phase 1 study to Study will evaluate safety, tolerability, and
pharmacokinetics of Single Ascending dose (SAD), Food effect (FE) and Multiple ascending dose
(MAD) of OR-101 Administered Orally in healthy subjects
Trial website
https://clinicaltrials.gov/ct2/show/NCT06045624
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06045624