NCT02454387

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

April 29, 2015

Last Update Submit

June 29, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

    Up to Day 28

Secondary Outcomes (6)

  • Maximum plasma concentration of ONO-4474 (Cmax)

    Day 1 and at Day 7

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

    Day 1 and at Day 7

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

    Day 1 and at Day 7

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

    Day 1 and at Day 7

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

    3hr and 24hr after NGF injection

  • +1 more secondary outcomes

Study Arms (10)

Experimental: ONO-4474 Part A1

EXPERIMENTAL

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

Drug: ONO-4474 Part A1

Experimental: ONO-4474 Placebo Part A1

PLACEBO COMPARATOR

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

Drug: Placebo Part A1

Experimental: ONO-4474 Part A2

EXPERIMENTAL

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

Drug: ONO-4474 Part A2

Experimental: ONO-4474 Placebo Part A2

PLACEBO COMPARATOR

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

Drug: Placebo Part A2

Experimental: ONO-4474 Part B

EXPERIMENTAL

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

Drug: ONO-4474 Part B

Experimental: ONO-4474 Placebo Part B

PLACEBO COMPARATOR

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

Drug: Placebo Part B

Experimental: ONO-4474 Part C

EXPERIMENTAL

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

Drug: ONO-4474 Part C

Experimental: ONO-4474 Placebo Part C

PLACEBO COMPARATOR

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

Drug: Placebo Part C

Experimental: ONO-4474 Part D

EXPERIMENTAL

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

Drug: ONO-4474 Part D

Experimental: ONO-4474 Placebo Part D

PLACEBO COMPARATOR

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

Drug: Placebo Part D

Interventions

ONO-4474 Part A1DRUG

Healthy volunteers

Also known as: ONO-4474
Experimental: ONO-4474 Part A1
Placebo Part A1DRUG

Healthy volunteers

Also known as: Placebo
Experimental: ONO-4474 Placebo Part A1
ONO-4474 Part A2DRUG

Healthy volunteers

Also known as: ONO-4474
Experimental: ONO-4474 Part A2
Placebo Part A2DRUG

Healthy volunteers

Also known as: Placebo
Experimental: ONO-4474 Placebo Part A2
ONO-4474 Part BDRUG

Healthy volunteers

Also known as: ONO-4474
Experimental: ONO-4474 Part B
Placebo Part BDRUG

Healthy volunteers

Also known as: Placebo
Experimental: ONO-4474 Placebo Part B
ONO-4474 Part CDRUG

Healthy volunteers

Also known as: ONO-4474
Experimental: ONO-4474 Part C
Placebo Part CDRUG

Healthy volunteers

Also known as: Placebo
Experimental: ONO-4474 Placebo Part C
ONO-4474 Part DDRUG

Healthy volunteers

Also known as: ONO-4474
Experimental: ONO-4474 Part D
Placebo Part DDRUG

Healthy volunteers

Also known as: Placebo
Experimental: ONO-4474 Placebo Part D

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aalborg Clinical Site

Aalborg, Denmark

Location

Nottingham Clinical SIte

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Drug Development Division

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-01

Locations

DK(1)GB(1)