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

Ono Pharmaceutical Co. Ltd141 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

141

Conditions

Osteoarthritis

Interventions

ONO-4474 Part A1DRUG

Healthy volunteers

Placebo Part A1DRUG

Healthy volunteers

ONO-4474 Part A2DRUG

Healthy volunteers

Placebo Part A2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 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

Locations (2)

Aalborg Clinical Site

Aalborg, Denmark

Nottingham Clinical SIte

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

Maximum plasma concentration of ONO-4474 (Cmax)

Time frame: Day 1 and at Day 7

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

Time frame: Day 1 and at Day 7

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

Time frame: Day 1 and at Day 7

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

Time frame: Day 1 and at Day 7

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

Time frame: 3hr and 24hr after NGF injection

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

Data from ClinicalTrials.gov

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