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ONO-2020 for Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by Ono Pharmaceutical Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a, c and d: from day 1 up to day 7, part b and e: from day 1 up to day 21
Awards & highlights

Summary

This trial is testing a new drug to see if it is safe and tolerated by healthy adults, including elderly and Japanese participants. They will also study how the new drug is affected by food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a, c and d: from day 1 up to day 7, part b and e: from day 1 up to day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a, c and d: from day 1 up to day 7, part b and e: from day 1 up to day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-lead electrocardiograms (ECGs) parameters, such as but not limited to heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF)
Clinical laboratory abnormalities (hematology, clinical chemistry, coagulation, and urinalysis)
Clinically abnormal findings in Columbia Suicide Severity Rating Scale (C-SSRS)
+9 more
Secondary outcome measures
Pharmacokinetics (AUCinf in plasma)
Pharmacokinetics (AUClast in plasma)
Bacteriuria
+8 more

Trial Design

16Treatment groups
Experimental Treatment
Group I: Part E: Cohort E2 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days in Japanese healthy volunteers
Group II: Part E: Cohort E1 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days in Japanese healthy volunteers
Group III: Part D: Cohort D1 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Single dose of ONO-2020 orally in elderly healthy volunteers
Group IV: Part C: Cohort C2 ONO-2020Experimental Treatment1 Intervention
Single dose of ONO-2020 orally for CSF sampling
Group V: Part C: Cohort C1 ONO-2020Experimental Treatment1 Intervention
Single dose of ONO-2020 orally for CSF sampling
Group VI: Part B: Cohort B5 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days
Group VII: Part B: Cohort B4 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days
Group VIII: Part B: Cohort B3 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days
Group IX: Part B: Cohort B2 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days
Group X: Part B: Cohort B1 ONO-2020 or PlaceboExperimental Treatment2 Interventions
Multiple ascending doses of ONO-2020 orally for 14 days
Group XI: Part A: Cohort A6 ONO-2020 or Placebo - fastedExperimental Treatment2 Interventions
Single ascending doses of ONO-2020 orally under fasted conditions
Group XII: Part A: Cohort A5 ONO-2020 or Placebo - fastedExperimental Treatment2 Interventions
Single ascending doses of ONO-2020 orally under fasted conditions
Group XIII: Part A: Cohort A4 ONO-2020 or Placebo - fasted and fedExperimental Treatment2 Interventions
Single ascending doses of ONO-2020 orally under fasted and fed conditions
Group XIV: Part A: Cohort A3 ONO-2020 or Placebo - fastedExperimental Treatment2 Interventions
Single ascending doses of ONO-2020 orally under fasted conditions
Group XV: Part A: Cohort A2 ONO-2020 or Placebo - fasted and fedExperimental Treatment2 Interventions
Single ascending doses of ONO-2020 orally under fasted and fed conditions
Group XVI: Part A: Cohort A1 ONO-2020 or Placebo - fastedExperimental Treatment2 Interventions
Single ascending doses of ONO-2020 orally under fasted conditions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONO-2020
2022
Completed Phase 1
~140
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdLead Sponsor
154 Previous Clinical Trials
94,391 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharma USA Inc
12 Previous Clinical Trials
2,481 Total Patients Enrolled
~45 spots leftby Jul 2025
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