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Testing APPA-1 in Healthy Subjects and Osteoarthritis Patients

NCT07429565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-24

No results posted yet for this study

Summary

To determine the safety and tolerability of ascending single and multiple oral doses of APPA-1 in healthy subjects and osteoarthritis patients.

To determine the single and multiple oral dose pharmacokinetics of APPA-1 constituents (paeonol/apocynin) in healthy subjects and osteoarthritis patients.

To determine the effect of food on the single oral dose pharmacokinetics of APPA-1 constituents (paeonol/apocynin) in healthy subjects.

To determine the effect of gender on the single oral dose pharmacokinetics of APPA-1 constituents (paeonol/apocynin) in healthy subjects.

To determine the multiple oral dose pharmacodynamics of APPA-1 in osteoarthritis patients.

Conditions

Interventions

DRUG

APPA-1

APPA is an acronym for the combination of apocynin (AP) and its isomer, paeonol (PA). It is an orally administered synthetic combination of two compounds: * 4'-hydroxy-3'-methoxy-acteophenone (apocynin\[acetovanillone\]); * 2'-hydroxy -4'-methoxy acetophenone (paeonol). The intention is that the two actives will be available as a fixed combination product. The proposed ratio is 7:2 (paeonol:apocynin).

DRUG

Placebo Oral Tablet

Identical to IMP apart from active substance.

Sponsors & Collaborators

  • AKL Research and Development

    collaborator INDUSTRY

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Rob Prof Moots, FRCP · Universiy of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429565 on ClinicalTrials.gov