132 Participants Needed

ONO-2020 for Healthy Participants

OP
OP
Overseen ByOno Pharma USA, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called ONO-2020 to see if it is safe and how it behaves in the body. It includes healthy adults, elderly people, and Japanese participants. Researchers want to understand how the drug is absorbed, processed, and eliminated from the body.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements at least 14 days before the study and throughout the study.

How is the drug ONO-2020 different from other treatments?

The unique aspect of ONO-2020 is not directly mentioned in the research, but it is being tested in healthy participants, which suggests it might be a novel drug with potential preventative or health-enhancing properties rather than treating an existing condition.12345

Who Is on the Research Team?

PL

Project Leader

Principal Investigator

Ono Pharma USA Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

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.
Fully vaccinated for SARS-CoV-2 (received primary series of COVID-19 vaccine) prior to Screening
Male and female participants of non-Japanese ethnicity (Parts A, B, C, and D) or of Japanese ethnicity (Part E)
See 9 more

Exclusion Criteria

History of poor venous access
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
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Part A

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

1 week
Multiple visits for dosing and monitoring

Treatment Part B

Multiple ascending doses of ONO-2020 orally for 14 days

2 weeks
Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-3 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ONO-2020
  • Placebo
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ono Pharmaceutical Co. Ltd

Lead Sponsor

Trials
182
Recruited
97,100+
Shinji Takai profile image

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara profile image

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University

Published Research Related to This Trial

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.
The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.
TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.Howick, J., Webster, RK., Rees, JL., et al.[2020]
This study investigates the effectiveness of a multispecies probiotic in preventing antibiotic-associated diarrhea in 56 individuals with spinal cord injury during their rehabilitation, using a double-blind, placebo-controlled design.
Participants will be monitored for bowel management and quality of life over a period of 5 weeks, allowing researchers to assess the probiotics' impact on diarrhea incidence and overall gastrointestinal health after antibiotic treatment.
Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.Faber, WXM., Nachtegaal, J., Stolwijk-Swuste, JM., et al.[2022]
In a study involving 100 patients undergoing lumbar spine fusion surgeries, batroxobin and its combination with tranexamic acid significantly reduced both intraoperative and postoperative blood loss compared to a placebo.
The mean intraoperative blood loss was lowest in the batroxobin group (268.32 mL) and the combination group (256.96 mL), indicating their effectiveness, while no significant differences were found in blood transfusion needs or complications like deep vein thrombosis.
Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery.Nagabhushan, RM., Shetty, AP., Dumpa, SR., et al.[2021]

Citations

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]
Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury. [2022]
Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery. [2021]
Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury. [2015]
Does Erector Spinae Plane Block Decrease Analgesia Requirements After Minimal-Invasive Posterior Transpedicular Stabilization in Patients With Vertebral Body Fracture? A Prospective, Randomized, Double-Blind Controlled Study. [2023]
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