A Phase 1 Study of ONO-2020 in Healthy Participants

NCT05507515 | Completed Phase 1 FDA Drug

• 1 other identifier: ONO-2020-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this FIH study is to evaluate the safety, tolerability and pharmacokinetics of ONO-2020 in healthy adult participants. This FIH study consists of five parts (Parts A-E) to study single or multiple doses of ONO-2020 in healthy participants, including elderly and Japanese participants, as well as the food effect on the PK of ONO-2020. These data will support the clinical development program and help inform dose selection in future studies.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (12)

• Incidence, severity, and type of treatment emergent adverse events (TEAEs)

  Incidence of TEAEs will be summarized overall, and by study part and dose group using frequency and percentage.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Vital signs (blood pressure)

  Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Vital signs (pulse rate)

  Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Vital signs (body temperature)

  Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Vital signs (respiratory rate)

  Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• 12-lead electrocardiograms (ECGs) parameters, such as but not limited to heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF)

  The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of ECG results will be tabulated at each time point.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Clinically significant abnormal telemetry electrocardiograms (ECGs)

  The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of telemetry ECGs results will be tabulated at each time point.

  Part A and D: Day 1

• Clinically significant abnormal physical examination findings

  The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of physical examination results will be tabulated at each time point.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Clinical laboratory abnormalities (hematology, clinical chemistry, coagulation, and urinalysis)

  The number and percentage of subjects with abnormal laboratory results at any time during the study will be tabulated.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Ophthalmologic examination findings (pupil size and pupillary light reflex)

  The number and percentage of subjects with miosis will be summarized by laterality at each time point.

  Part A, C and D: From Day 1 up to Day 7, Part B and E: From Day 1 up to Day 21

• Clinically abnormal findings in Mini-International Neuropsychiatric Interview Screen (M.I.N.I.-Screen)

  Responses to the M.I.N.I.-Screen will be listed.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

• Clinically abnormal findings in Columbia Suicide Severity Rating Scale (C-SSRS)

  Responses to the suicidality assessment scale (C-SSRS) will be listed.

  Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21

Secondary Outcomes (11)

• Pharmacokinetics (Cmax in plasma)

  Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19

• Pharmacokinetics (Tmax in plasma)

  Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19

• Pharmacokinetics (AUClast in plasma)

  Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19

• Pharmacokinetics (AUCinf in plasma)

  Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19

• Pharmacokinetics (T1/2 in plasma)

  Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19

Study Arms (16)

Part A: Cohort A1 ONO-2020 or Placebo - fasted

EXPERIMENTAL

Single ascending doses of ONO-2020 orally under fasted conditions

Drug: ONO-2020; Drug: Placebo

Part A: Cohort A2 ONO-2020 or Placebo - fasted and fed

EXPERIMENTAL

Single ascending doses of ONO-2020 orally under fasted and fed conditions

Drug: ONO-2020; Drug: Placebo

Part A: Cohort A3 ONO-2020 or Placebo - fasted

EXPERIMENTAL

Single ascending doses of ONO-2020 orally under fasted conditions

Drug: ONO-2020; Drug: Placebo

Part A: Cohort A4 ONO-2020 or Placebo - fasted and fed

EXPERIMENTAL

Single ascending doses of ONO-2020 orally under fasted and fed conditions

Drug: ONO-2020; Drug: Placebo

Part A: Cohort A5 ONO-2020 or Placebo - fasted

EXPERIMENTAL

Single ascending doses of ONO-2020 orally under fasted conditions

Drug: ONO-2020; Drug: Placebo

Part A: Cohort A6 ONO-2020 or Placebo - fasted

EXPERIMENTAL

Single ascending doses of ONO-2020 orally under fasted conditions

Drug: ONO-2020; Drug: Placebo

Part B: Cohort B1 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days

Drug: ONO-2020; Drug: Placebo

Part B: Cohort B2 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days

Drug: ONO-2020; Drug: Placebo

Part B: Cohort B3 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days

Drug: ONO-2020; Drug: Placebo

Part B: Cohort B4 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days

Drug: ONO-2020; Drug: Placebo

Part B: Cohort B5 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days

Drug: ONO-2020; Drug: Placebo

Part C: Cohort C1 ONO-2020

EXPERIMENTAL

Single dose of ONO-2020 orally for CSF sampling

Drug: ONO-2020

Part C: Cohort C2 ONO-2020

EXPERIMENTAL

Single dose of ONO-2020 orally for CSF sampling

Drug: ONO-2020

Part D: Cohort D1 ONO-2020 or Placebo

EXPERIMENTAL

Single dose of ONO-2020 orally in elderly healthy volunteers

Drug: ONO-2020; Drug: Placebo

Part E: Cohort E1 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days in Japanese healthy volunteers

Drug: ONO-2020; Drug: Placebo

Part E: Cohort E2 ONO-2020 or Placebo

EXPERIMENTAL

Multiple ascending doses of ONO-2020 orally for 14 days in Japanese healthy volunteers

Drug: ONO-2020; Drug: Placebo

Interventions

ONO-2020 DRUG

ONO-2020 tablets

Part A: Cohort A1 ONO-2020 or Placebo - fasted; Part A: Cohort A2 ONO-2020 or Placebo - fasted and fed; Part A: Cohort A3 ONO-2020 or Placebo - fasted; Part A: Cohort A4 ONO-2020 or Placebo - fasted and fed; Part A: Cohort A5 ONO-2020 or Placebo - fasted; Part A: Cohort A6 ONO-2020 or Placebo - fasted; Part B: Cohort B1 ONO-2020 or Placebo; Part B: Cohort B2 ONO-2020 or Placebo; Part B: Cohort B3 ONO-2020 or Placebo; Part B: Cohort B4 ONO-2020 or Placebo; Part B: Cohort B5 ONO-2020 or Placebo; Part C: Cohort C1 ONO-2020; Part C: Cohort C2 ONO-2020; Part D: Cohort D1 ONO-2020 or Placebo; Part E: Cohort E1 ONO-2020 or Placebo; Part E: Cohort E2 ONO-2020 or Placebo

Placebo DRUG

Placebo tablets matching ONO-2020 tablets

Part A: Cohort A1 ONO-2020 or Placebo - fasted; Part A: Cohort A2 ONO-2020 or Placebo - fasted and fed; Part A: Cohort A3 ONO-2020 or Placebo - fasted; Part A: Cohort A4 ONO-2020 or Placebo - fasted and fed; Part A: Cohort A5 ONO-2020 or Placebo - fasted; Part A: Cohort A6 ONO-2020 or Placebo - fasted; Part B: Cohort B1 ONO-2020 or Placebo; Part B: Cohort B2 ONO-2020 or Placebo; Part B: Cohort B3 ONO-2020 or Placebo; Part B: Cohort B4 ONO-2020 or Placebo; Part B: Cohort B5 ONO-2020 or Placebo; Part D: Cohort D1 ONO-2020 or Placebo; Part E: Cohort E1 ONO-2020 or Placebo; Part E: Cohort E2 ONO-2020 or Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 55 years of age (Parts A, B, C, and E) or ≥65 years of age (Part D) inclusive at the time of informed consent.
• Male and female participants of non-Japanese ethnicity (Parts A, B, C, and D) or of Japanese ethnicity (Part E).
• No clinically significant medical history and no abnormal physical examination, laboratory profiles, vital signs or ECG abnormalities, based on the Screening examination.
• Body mass index of ≥18.5 to \<30 kg/m2, and a body weight of at least 50 kg for males and 45 kg for females to a maximum of 100 kg, at the time of Screening.
• Agree to use an effective method of contraception.
• Able and willing to give informed consent after reading the information and consent form and after having the opportunity to discuss the study with the Investigator or designee.
• Estimated creatinine clearance (CrCL, Cockcroft-Gault equation) ≥90 mL/min at Screening. In Part D only, an estimated ≥60 mL/min at Screening.
• Fully vaccinated for SARS-CoV-2 (received primary series of COVID-19 vaccine) prior to Screening.

You may not qualify if:

• Mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical, surgical or psychiatric condition or disease that in the opinion of the Investigator or Sponsor Medical Monitor might confound the results of the study or pose an additional risk to the participant by their participation in the study.
• hypersensitivity or idiosyncratic reaction to the study interventions, excipients or related compounds, or severe food allergies.
• alcoholism or drug/chemical/substance abuse within the past 2 years prior to the first dosing.
• Use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements, including St. John's Wort, within 14 days or five half-lives (whichever is longer) of first dosing and throughout the study.
• Use of any drugs known to be significant inducers or inhibitors of cytochrome P450 (CYP) enzymes and/or drug transporter substrates for 28 days prior to the first dosing and throughout the study.
• Participation in another clinical study within 120 days (or five half-lives of the study intervention, whichever is longer) prior to the first dosing.
• Positive urine drug, alcohol, or cotinine results at Screening or check in.
• Positive results at Screening for active viral infection that include HIV, HBV, HCV, and SARS-CoV-2.
• Seated resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening.
• Seated resting pulse rate is lower than 40 beats per minute (bpm) or higher than 100 bpm at Screening.
• Clinically significant history or presence of ECG findings.
• The participant is a current smoker or has smoked within 3 months of Screening or has a positive urine cotinine at Screening or admission.
• Female who is pregnant or lactating.
• Donation of blood or significant blood loss of 400 mL or more within 90 days prior to the first dosing, or blood donation of 200 mL or more within 30 days prior to the first dosing, or blood plasma or platelet donation within 14 days prior to the first dosing, or blood transfusion within 90 days prior to the first dosing.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

Altasciences

Cypress, California, 90630, United States

Location

Study Officials

• Project Leader

  Ono Pharma USA Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 19, 2022
• Study Start: July 29, 2022
• Primary Completion: December 24, 2023
• Study Completion: December 24, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)