Alopecia AreataPhase 1NCT06045624
A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects
A Phase 1 study testing OR-101 (Single ascending dose), OR-101 (Food effect) and OR-101 (Multiple ascending dose) in people with Alopecia Areata, run by Ornovi, Inc. at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- OR-101 (Single ascending dose), OR-101 (Food effect) and OR-101 (Multiple ascending dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Oct 2023to 6 Feb 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is willing to sign and date IRB-approved ICF.
- Is a man or woman between the ages of 18 and 55, inclusive.
- 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.
- 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).
- 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).
- If a woman of childbearing potential, must not be pregnant, lactating, or planning to become pregnant during the study.
- Willing to follow the methods of contraception as per the protocol.
Who cannot join
- Has any condition that precludes a subject's ability to comply with study requirements, including completion of the study visits.
- 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.
- Has clinically significant abnormal laboratory test values as determined by the Investigator or the local or Sponsor Medical Monitor.
- 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
Show all 25Show fewer
- HR >100 or <50 bpm
- 2 repeats of the subject's BP or HR are permitted for eligibility purposes
- 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.
- Has unacceptable COVID-19 test results (if required per site policy at the time of enrollment).
- 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.
- Has a history of tuberculosis.
- Has an active immune suppressed condition or disease.
- 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).
- 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.
- 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.
- 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.
- Has recent history (within 6 months of screening) of alcohol or drug abuse.
- 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.
- 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.
- 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).
- 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.
- Has donated blood > 500 mL within 60 days prior to the Screening Visit (Plasma donation is allowed).
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
SCIENTIA Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official 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
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
Read the detailed description
There are three phases of the study: Single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) phases.
In the SAD and MAD Phases, up to 64 subjects in each phase may be enrolled in the study. Fortyeight subjects will be randomised in the initial six cohorts; upto 16 subjects may be enrolled in two additional cohorts. For each dose cohort a total of 8 subjects (6 receiving OR-101 and 2 placebo) will be enrolled and randomized.
In the FE phase, up to 8 subjects who will receive a high fat meal prior to administration of OR101 may be enrolled in the study. Subjects who discontinue prior to completion may be replaced at the discretion of the Sponsor and the Investigator.
The SRC including the Investigator, Medical Monitor, Study Director as well as other ad hoc representatives as appropriate will regularly monitor all aspects of subject safety throughout this study. The SRC will review all available, cumulative safety and PK data in a blinded manner to assess the safety of each dose level of OR-101 prior to escalating to the next dose level.
- Conditions
- Alopecia Areata
- Being tested
- OR-101 (Single ascending dose), OR-101 (Food effect), OR-101 (Multiple ascending dose), Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR-101 (Single ascending dose)Drug
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.
OR-101 (Food effect)Drug
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
OR-101 (Multiple ascending dose)Drug
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
PlaceboDrug
Participants will receive matching placebo across Part A and C of the study
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | 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 Receives: Drug: OR-101 (Single ascending dose) |
| Part B | Experimental | 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 Receives: Drug: OR-101 (Food effect) |
| Part C | Experimental | 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 Receives: Drug: OR-101 (Multiple ascending dose) |
| Placebo | Placebo comparator | Placebo comparators taken by participants randomised to the placebo arm across Part A and C of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment emergent Adverse events (TEAEs)
Measured: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Number of participants with Serious Adverse events (SAEs)
Measured: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Number of participants with changes in 12-lead ECG findings
Measured: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Number of participants in clinical laboratory tests
Measured: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Secondary outcomes (6)
PK Parameters: Maximum Concentration (Cmax)
Measured: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
PK Parameters: Tmax
Measured: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
PK Parameters: Area under the curve (AUC)
Measured: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
PK Parameters: half life (t1/2)
Measured: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
Urine PK Parameters: Renal Clearance (CLr)
Measured: 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.
Urine PK Parameters: nonrenal Clearance (CLnr)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Oct 2023 (estimated)
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Why it stopped: The study was cancelled as the sponsor decided to reformulate the IP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ornovi, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045624
- Sponsor's protocol ID
- OR101-HS101
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06045624
- Acronym / sponsor ID
- OR101-HS101
- Conditions
- Alopecia Areata
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was cancelled as the sponsor decided to reformulate the IP
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ornovi, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (estimated)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 21 Sep 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.
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
Detailed description
There are three phases of the study: Single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) phases.
In the SAD and MAD Phases, up to 64 subjects in each phase may be enrolled in the study. Fortyeight subjects will be randomised in the initial six cohorts; upto 16 subjects may be enrolled in two additional cohorts. For each dose cohort a total of 8 subjects (6 receiving OR-101 and 2 placebo) will be enrolled and randomized.
In the FE phase, up to 8 subjects who will receive a high fat meal prior to administration of OR101 may be enrolled in the study. Subjects who discontinue prior to completion may be replaced at the discretion of the Sponsor and the Investigator.
The SRC including the Investigator, Medical Monitor, Study Director as well as other ad hoc representatives as appropriate will regularly monitor all aspects of subject safety throughout this study. The SRC will review all available, cumulative safety and PK data in a blinded manner to assess the safety of each dose level of OR-101 prior to escalating to the next dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: OR-101 (Single ascending dose)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 |
| Part B | Experimental | Drug: OR-101 (Food effect)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 |
| Part C | Experimental | Drug: OR-101 (Multiple ascending dose)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 | Placebo comparator | Drug: PlaceboPlacebo comparators taken by participants randomised to the placebo arm across Part A and C of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Is willing to sign and date IRB-approved ICF.
- Is a man or woman between the ages of 18 and 55, inclusive.
- 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.
- 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).
- 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).
Key exclusion criteria (25 listed)
- Has any condition that precludes a subject's ability to comply with study requirements, including completion of the study visits.
- 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.
- Has clinically significant abnormal laboratory test values as determined by the Investigator or the local or Sponsor Medical Monitor.
- has BP and HR measurement after 5 minutes rest in a supine position of:
- 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.
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 |
|---|---|---|
| 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. | Drug | Part A |
| 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 | Drug | Part B |
| 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 | Drug | Part C |
| PlaceboParticipants will receive matching placebo across Part A and C of the study | Drug | Placebo |
Primary outcome
Number of participants with Treatment emergent Adverse events (TEAEs)
Time frame: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Number of participants with Serious Adverse events (SAEs)
Time frame: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Number of participants with changes in 12-lead ECG findings
Time frame: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Number of participants in clinical laboratory tests
Time frame: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
6 secondary outcomes
PK Parameters: Maximum Concentration (Cmax)
Time frame: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
PK Parameters: Tmax
Time frame: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
PK Parameters: Area under the curve (AUC)
Time frame: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
PK Parameters: half life (t1/2)
Time frame: SAD and FE- Day1, Day2, Day 3, Day 4 and day 8 post dose; MAD- Day 1 to Day 14 post dose
Urine PK Parameters: Renal Clearance (CLr)
Time frame: 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.
Urine PK Parameters: nonrenal Clearance (CLnr)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 OR-101 (Single ascending dose), OR-101 (Food effect) and OR-101 (Multiple ascending dose) in people with Alopecia Areata, run by Ornovi, Inc. 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 7 inclusion and 25 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: withdrawn, as of the sponsor's last update on 5 Apr 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with Treatment emergent Adverse events (TEAEs) (time frame: Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2024.