ONO-2020 for Healthy Participants

Overseen By Ono Pharma USA, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ono Pharmaceutical Co. Ltd

Must not be taking: CYP inducers/inhibitors, St. John's Wort

Disqualifiers: Alcoholism, Drug abuse, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and metabolism of a new drug, ONO-2020, in healthy adults. As a Phase 1 study, it marks the first time this drug is tested in humans. Participants will receive varying doses to assess its effects, including the impact of food intake. Healthy individuals with no significant medical history may be suitable candidates for this trial. As part of a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ONO-2020 is under study to determine its safety for healthy individuals. In studies involving patients with conditions like Alzheimer's, ONO-2020 has generally been well-tolerated, with most participants experiencing no serious side effects. However, since this study is in its early stages, the focus is on understanding how the body handles the drug—its absorption, processing, and elimination—and ensuring safety at various doses. This step is common in testing new treatments, so information about long-term safety or rare side effects may not yet be available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ONO-2020 is unique because it explores a novel mechanism of action that might offer a fresh approach compared to typical treatments. While most existing therapies work by targeting specific symptoms or pathways, ONO-2020 could potentially act on different biological targets, providing a new angle for treatment. Researchers are particularly excited about its potential for rapid effectiveness and diverse applicability, with trials exploring different dosing regimens and conditions. This versatility could make ONO-2020 a promising addition to the current treatment landscape.

What evidence suggests that ONO-2020 could be effective?

Research has shown that ONO-2020 can influence gene function. Animal studies suggest it might improve memory and slow the progression of Alzheimer's disease. This trial tests ONO-2020 in healthy participants to evaluate its safety and potential effects. Early results from other studies indicate it could help with cognitive symptoms in people with mild to moderate memory and thinking problems. However, the research remains in its early stages, and further studies are needed to confirm these effects in humans. ^{1 2 3 4 5}

Who Is on the Research Team?

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)

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

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?

Group I: Part E: Cohort E2 ONO-2020 or Placebo Experimental Treatment 2 Interventions

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

Group II: Part E: Cohort E1 ONO-2020 or Placebo Experimental Treatment 2 Interventions

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

Group III: Part D: Cohort D1 ONO-2020 or Placebo Experimental Treatment 2 Interventions

Single dose of ONO-2020 orally in elderly healthy volunteers

Group IV: Part C: Cohort C2 ONO-2020 Experimental Treatment 1 Intervention

Single dose of ONO-2020 orally for CSF sampling

Group V: Part C: Cohort C1 ONO-2020 Experimental Treatment 1 Intervention

Single dose of ONO-2020 orally for CSF sampling

Group VI: Part B: Cohort B5 ONO-2020 or Placebo Experimental Treatment 2 Interventions

Multiple ascending doses of ONO-2020 orally for 14 days

Group VII: Part B: Cohort B4 ONO-2020 or Placebo Experimental Treatment 2 Interventions

Multiple ascending doses of ONO-2020 orally for 14 days

Group VIII: Part B: Cohort B3 ONO-2020 or Placebo Experimental Treatment 2 Interventions

Multiple ascending doses of ONO-2020 orally for 14 days

Group IX: Part B: Cohort B2 ONO-2020 or Placebo Experimental Treatment 2 Interventions

Multiple ascending doses of ONO-2020 orally for 14 days

Group X: Part B: Cohort B1 ONO-2020 or Placebo Experimental Treatment 2 Interventions

Multiple ascending doses of ONO-2020 orally for 14 days

Group XI: Part A: Cohort A6 ONO-2020 or Placebo - fasted Experimental Treatment 2 Interventions

Single ascending doses of ONO-2020 orally under fasted conditions

Group XII: Part A: Cohort A5 ONO-2020 or Placebo - fasted Experimental Treatment 2 Interventions

Single ascending doses of ONO-2020 orally under fasted conditions

Group XIII: Part A: Cohort A4 ONO-2020 or Placebo - fasted and fed Experimental Treatment 2 Interventions

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

Group XIV: Part A: Cohort A3 ONO-2020 or Placebo - fasted Experimental Treatment 2 Interventions

Single ascending doses of ONO-2020 orally under fasted conditions

Group XV: Part A: Cohort A2 ONO-2020 or Placebo - fasted and fed Experimental Treatment 2 Interventions

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

Group XVI: Part A: Cohort A1 ONO-2020 or Placebo - fasted Experimental Treatment 2 Interventions

Single ascending doses of ONO-2020 orally under fasted conditions

Who Is Running the Clinical Trial?

Ono Pharmaceutical Co. Ltd

Lead Sponsor

Trials

182

Recruited

97,100+

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University

Published Research Related to This Trial

The use of an ESP block during minimally invasive spinal surgery significantly reduced opioid consumption by 37.7% in the first 48 hours post-surgery, indicating its efficacy in pain management.

Patients receiving the ESP block reported lower pain levels (measured by VAS) and improved short-term outcomes (PROST scores) compared to the placebo group, although there were no significant differences in blood loss or wound healing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Holas, M., Hlásny, J., Gajdoš, R., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06881836

A Study of ONO-2020 in Participants With Mild to Moderate ... This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition.

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-6-2022-51bcb

ONO-2020 for Healthy Participants The use of an ESP block during minimally invasive spinal surgery significantly reduced opioid consumption by 37.7% in the first 48 hours post-surgery, ...

3. ctv.veeva.com ctv.veeva.com/study/a-phase-1-study-of-ono-2020-in-healthy-participants

A Phase 1 Study of ONO-2020 in Healthy Participants The purpose of this FIH study is to evaluate the safety, tolerability and pharmacokinetics of ONO-2020 in healthy adult participants.

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/570717

A Study of ONO-2020 in Patients With Agitation Associated ... To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan. Fill out a short questionnaire ...

5. studypages.com studypages.com/s/a-study-of-ono-2020-in-participants-with-mild-to-moderate-alzheimers-disease-552752/

A Study of ONO-2020 in Participants With Mild to Moderate ... ONO-2020 shows the potential to provide symptomatic cognition improvement and to slow the progression of AD in animal studies. This is a Phase 2 study. Phase 2 ...