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CompletedNCT02454387Updated Jun 30, 2016

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers

A Phase 1 interventional study of ONO-4474 Part A1 and Placebo Part A1 in Osteoarthritis, sponsored by Ono Pharmaceutical Co., Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-30.

Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.

Read the detailed description

A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.

02

Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 141 is above the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.

Browse Ono Pharmaceutical Co. Ltd studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
  2. Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
  2. Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
141 participants (actual)

Study arms

  • Experimental
    Experimental: ONO-4474 Part A1

    Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: ONO-4474 Part A1

  • Placebo comparator
    Experimental: ONO-4474 Placebo Part A1

    Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: Placebo Part A1

  • Experimental
    Experimental: ONO-4474 Part A2

    Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: ONO-4474 Part A2

  • Placebo comparator
    Experimental: ONO-4474 Placebo Part A2

    Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: Placebo Part A2

  • Experimental
    Experimental: ONO-4474 Part B

    Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: ONO-4474 Part B

  • Placebo comparator
    Experimental: ONO-4474 Placebo Part B

    Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: Placebo Part B

  • Experimental
    Experimental: ONO-4474 Part C

    NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design

    Drug: ONO-4474 Part C

  • Placebo comparator
    Experimental: ONO-4474 Placebo Part C

    NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design

    Drug: Placebo Part C

  • Experimental
    Experimental: ONO-4474 Part D

    Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: ONO-4474 Part D

  • Placebo comparator
    Experimental: ONO-4474 Placebo Part D

    Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

    Drug: Placebo Part D

Interventions

  • DrugONO-4474 Part A1

    Healthy volunteers

    Also known as: ONO-4474

  • DrugPlacebo Part A1

    Healthy volunteers

    Also known as: Placebo

  • DrugONO-4474 Part A2

    Healthy volunteers

    Also known as: ONO-4474

  • DrugPlacebo Part A2

    Healthy volunteers

    Also known as: Placebo

  • DrugONO-4474 Part B

    Healthy volunteers

    Also known as: ONO-4474

  • DrugPlacebo Part B

    Healthy volunteers

    Also known as: Placebo

  • DrugONO-4474 Part C

    Healthy volunteers

    Also known as: ONO-4474

  • DrugPlacebo Part C

    Healthy volunteers

    Also known as: Placebo

  • DrugONO-4474 Part D

    Healthy volunteers

    Also known as: ONO-4474

  • DrugPlacebo Part D

    Healthy volunteers

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events

    Time frame: Up to Day 28

Secondary outcomes

  1. Maximum plasma concentration of ONO-4474 (Cmax)

    Time frame: Day 1 and at Day 7

  2. ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)

    Time frame: Day 1 and at Day 7

  3. Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474

    Time frame: Day 1 and at Day 7

  4. Plasma Decay half life (T1/2) of ONO-4474

    Time frame: Day 1 and at Day 7

  5. Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale

    Time frame: 3hr and 24hr after NGF injection

  6. Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.

    Pressure algometry at site of NGF injection (anterior tibialis)

    Time frame: 3hr and 24hr after NGF injection

07

Study locations

2 sites
  • Aalborg Clinical Site
    Aalborg, Denmark
  • Nottingham Clinical SIte
    Nottingham, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02454387
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 27, 2015
Start date
May 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Jun 30, 2016

Study contacts

Drug Development Division
study director · Ono Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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