Part C: Cohort C2 ONO-2020 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Altasciences, Cypress, CA
Healthy Subjects (HS)
ONO-2020 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

12 Primary · 11 Secondary · Reporting Duration: Part A, C and D: From Day 1 up to Day 7, Part B and E: From Day 1 up to Day 21

Day 1
Clinically significant abnormal telemetry electrocardiograms (ECGs)
Day 4
Pharmacokinetics (Aet in urine)
Pharmacokinetics (CLR in urine)
Pharmacokinetics (fe/F in urine)
Day 19
Pharmacokinetics (AUCinf in plasma)
Pharmacokinetics (AUClast in plasma)
Pharmacokinetics (CL/F in plasma)
Pharmacokinetics (Cmax in plasma)
Pharmacokinetics (T1/2 in plasma)
Pharmacokinetics (Tmax in plasma)
Day 21
Ophthalmologic examination findings (pupil size and pupillary light reflex)
Day 21
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)
Clinically abnormal findings in Mini-International Neuropsychiatric Interview Screen (M.I.N.I.-Screen)
Clinically significant abnormal physical examination findings
Incidence, severity, and type of treatment emergent adverse events (TEAEs)
Vital signs (blood pressure)
Vital signs (body temperature)
Vital signs (pulse rate)
Vital signs (respiratory rate)
Day 13
Pharmacokinetics (Ctrough in plasma)
Part C: Day 2
Pharmacokinetics (ONO-2020 concentration in CSF)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

16 Treatment Groups

Part B: Cohort B4 ONO-2020 or Placebo
1 of 16
Part C: Cohort C2 ONO-2020
1 of 16
Part B: Cohort B5 ONO-2020 or Placebo
1 of 16
Part A: Cohort A4 ONO-2020 or Placebo - fasted and fed
1 of 16
Part B: Cohort B3 ONO-2020 or Placebo
1 of 16
Part A: Cohort A6 ONO-2020 or Placebo - fasted
1 of 16
Part E: Cohort E2 ONO-2020 or Placebo
1 of 16
Part A: Cohort A1 ONO-2020 or Placebo - fasted
1 of 16
Part E: Cohort E1 ONO-2020 or Placebo
1 of 16
Part C: Cohort C1 ONO-2020
1 of 16
Part A: Cohort A2 ONO-2020 or Placebo - fasted and fed
1 of 16
Part B: Cohort B2 ONO-2020 or Placebo
1 of 16
Part A: Cohort A5 ONO-2020 or Placebo - fasted
1 of 16
Part B: Cohort B1 ONO-2020 or Placebo
1 of 16
Part D: Cohort D1 ONO-2020 or Placebo
1 of 16
Part A: Cohort A3 ONO-2020 or Placebo - fasted
1 of 16
Experimental Treatment

138 Total Participants · 16 Treatment Groups

Primary Treatment: Part C: Cohort C2 ONO-2020 · Has Placebo Group · Phase 1

Part B: Cohort B4 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part C: Cohort C2 ONO-2020
Drug
Experimental Group · 1 Intervention: ONO-2020 · Intervention Types: Drug
Part B: Cohort B5 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part A: Cohort A4 ONO-2020 or Placebo - fasted and fedExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part B: Cohort B3 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part A: Cohort A6 ONO-2020 or Placebo - fastedExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part E: Cohort E2 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part A: Cohort A1 ONO-2020 or Placebo - fastedExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part E: Cohort E1 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part C: Cohort C1 ONO-2020
Drug
Experimental Group · 1 Intervention: ONO-2020 · Intervention Types: Drug
Part A: Cohort A2 ONO-2020 or Placebo - fasted and fedExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part B: Cohort B2 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part A: Cohort A5 ONO-2020 or Placebo - fastedExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part B: Cohort B1 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part D: Cohort D1 ONO-2020 or PlaceboExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Part A: Cohort A3 ONO-2020 or Placebo - fastedExperimental Group · 2 Interventions: ONO-2020, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: part a, c and d: from day 1 up to day 7, part b and e: from day 1 up to day 21
Closest Location: Altasciences · Cypress, CA
2021First Recorded Clinical Trial
8 TrialsResearching Healthy Subjects (HS)
17 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 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.
You are 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.
You have received primary series of COVID-19 vaccine.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.