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

NCT06045624 | Withdrawn Phase 1 DMC

• 1 other identifier: OR101-HS101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (4)

• Number of participants with Treatment emergent Adverse events (TEAEs)

  Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase

• Number of participants with Serious Adverse events (SAEs)

  Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase

• Number of participants with changes in 12-lead ECG findings

  Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase

• Number of participants in clinical laboratory tests

  Upto 8 days in SAD and FE Phase; Upto 14 days in MAD Phase

Secondary Outcomes (6)

• PK Parameters: Maximum Concentration (Cmax)

  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

  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)

  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)

  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)

  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.

Study Arms (4)

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

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

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

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.

Drug: Placebo

Interventions

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.

Part A

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

Part B

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

Part C

Placebo DRUG

Participants will receive matching placebo across Part A and C of the study

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ornovi, Inc.: lead

Study Sites (1)

SCIENTIA Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 17, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)