search
Back to results

A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects

Primary Purpose

Alopecia Areata

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
OR-101 (Single ascending dose)
OR-101 (Food effect)
OR-101 (Multiple ascending dose)
Placebo
Sponsored by
Ornovi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Sites / Locations

  • SCIENTIA Clinical Research Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part A

Part B

Part C

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of participants with Treatment emergent Adverse events (TEAEs)
Number of participants with Serious Adverse events (SAEs)
Number of participants with changes in 12-lead ECG findings
Number of participants in clinical laboratory tests

Secondary Outcome Measures

PK Parameters: Maximum Concentration (Cmax)
PK Parameters: Tmax
PK Parameters: Area under the curve (AUC)
PK Parameters: half life (t1/2)
Urine PK Parameters: Renal Clearance (CLr)
Urine PK Parameters: nonrenal Clearance (CLnr)

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Ornovi, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06045624
Brief Title
A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 17, 2023 (Anticipated)
Primary Completion Date
June 3, 2024 (Anticipated)
Study Completion Date
June 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ornovi, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A
Arm Type
Experimental
Arm Description
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
Arm Title
Part B
Arm Type
Experimental
Arm Description
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
Arm Title
Part C
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparators taken by participants randomised to the placebo arm across Part A and C of the study.
Intervention Type
Drug
Intervention Name(s)
OR-101 (Single ascending dose)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
OR-101 (Food effect)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
OR-101 (Multiple ascending dose)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo across Part A and C of the study
Primary Outcome Measure Information:
Title
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
Title
Number of participants with Serious Adverse events (SAEs)
Time Frame
Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Title
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
Title
Number of participants in clinical laboratory tests
Time Frame
Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wajdie Ahmad
Phone
(949) 873-4028
Email
info@ornovi.com
Facility Information:
Facility Name
SCIENTIA Clinical Research Ltd
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Argent, Dr
Phone
+61 2 9382 5844
Email
christopher.argent@scientiaclinicalresearch.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects

We'll reach out to this number within 24 hrs