A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants With Osteoarthritis of the Knee

Xgene Pharmaceutical Group1 site in 1 country32 target enrollmentJune 7, 2022

ConditionsPain

InterventionsXG004 Placebo

DrugsXG004 Placebo

Overview

Phase: Phase 1
Intervention: XG004
Conditions: Pain
Sponsor: Xgene Pharmaceutical Group
Enrollment: 32
Locations: 1
Primary Endpoint: To evaluate the safety and tolerability of topical XG004 applied to the study knee in Osteoarthritis (OA) participants through incidence of Treatment Emergent Adverse Events as assessed by CTCAE v5.0
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee

Detailed Description

The study will consist of a 4-week Screening period, an 7-day Treatment period and a 7-day Safety follow-up period that will be conducted by telephone for each Cohort. Up to 32 participants with OA of the knee will be enrolled into 6 cohorts sequentially and assigned treatment on a 3:1 (XG004: placebo) ratio.

Registry

clinicaltrials.gov

Start Date

June 7, 2022

End Date

March 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Xgene Pharmaceutical Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent form.
•Body Mass Index (BMI) of 18 to 39, inclusive, at the time of Screening visit.
•Participant who is diagnosed with primary knee OA fulfilling the American College of Rheumatology (ACR) Clinical and Radiographic criteria for ≥ 26 weeks prior to Screening visit.
•Kellgren-Lawrence Grade II to IV as confirmed by X-ray during Screening visit or within 6 months prior to Screening visit in the study knee.
•The average daily walking pain scale in the study knee over Day -4 to Day -2 during the Baseline period must be ≥ 4.0 on NRS 0-10 scale.

Exclusion Criteria

•Participants with any systemic or dermatological disorder that may interfere with the evaluation of the test site reactions (e.g., atopic dermatitis, contact eczema, psoriasis).
•Participants with scars, moles, tattoos at application site or other abnormal pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results.
•Participants with any of the following conditions on the test area: viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, acne vulgaris, atrophic skin, striae atrophic, fragility of skin veins, ichthyosis, ulcers or wounds.
•Participants exposed to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, solarium); and waxing, laser/IPL hair removal, fake/spray tanning is prohibited 14 days prior to enrollment or who may foresee an intensive UV exposure or swimming during study participation.
•Known hypersensitivity or allergy to NSAIDs or gabapentinoids or any component(s) of the investigational products. This includes participants exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.
•Participants with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), hematological, or psychiatric system as indicated on medical history, physical examination, or clinical laboratory, vital signs, and ECG evaluations, or in the opinion of the Investigator.
•Participants with any report of acute illness or febrile event within 72 hours prior to randomization.
•Known positive coronavirus disease 2019 (COVID-19) viral test during Screening or within 3 days prior to Day -1, or suspected COVID-19 infection at check-in on Day -1 visit.
•Participants who cannot refrain from strenuous exercise from 72 hours prior to first study dose through completion of the Safety follow-up visit
•Any other condition that, in the opinion of the investigator, would jeopardize the safety of the study participant or impact the validity of the study results

Arms & Interventions

A (XG004)

XG004 in two dose level (5% or 10%) will be applied to the targeted knee

Intervention: XG004

B (Placebo)

Placebo in all cohorts will be applied to the targeted knee.

Intervention: Placebo

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of topical XG004 applied to the study knee in Osteoarthritis (OA) participants through incidence of Treatment Emergent Adverse Events as assessed by CTCAE v5.0

Time Frame: From baseline to end of treatment up to 14 days

Secondary Outcomes

To examine skin response(From day 1 to day 8)
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.(From baseline to end of treatment up to 8 days)
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments(From baseline to end of treatment up to 8 days)
To explore the penetration of XG004 into the synovial fluid of the knee. Synovial fluid samples will be evaluated for the drug concentrations.(Day 8)