Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of AZD3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.

Official Title
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A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Determine the Effect of Intradermal AZD3161 on Quantitative Sensory Testing Variables in Normal and UVC Exposed Skin in Healthy Volunteers

Conditions
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Peripheral Neuropathic Pain, Nociceptive Pain

Intervention / Treatment
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* Drug: AZD3161
* Drug: Lidocaine
* Drug: AZD3161 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Caucasian male and female volunteers aged 18 to 55 years inclusive with suitable veins for venepuncture The subject belongs to skin type II or III according to Fitzpatrick skin type scale Females must have a negative pregnancy test at screening and at admission, must not be lactating and must be of non-child-bearing potential Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh between 50 kg and 100 kg inclusive Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with investigational product. Exclusion Criteria: Presence of skin disorders, tattoos or other skin conditions that may interfere with the QST measurements, as judged by the Investigator Recent exposure to significant amount of UV light, as judged by the Investigator. Use of any prescribed or non-prescribed analgesics (including paracetamol/acetaminophen or drugs affecting blood flow (including nasal anticongestants), prior to the first administration of investigational product that may interfere with the study objectives. History of severe allergy/hypersensitivity, or ongoing allergy/hypersensitivity as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3161. Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>150 μL intradermal injection of 1 μmol/L AZD3161 | Drug: AZD3161<br>* Single dose, intradermal injection<br>|
| Experimental: 2<br>150 μL intradermal injection of 6 μmol/L AZD3161 | Drug: AZD3161<br>* Single dose, intradermal injection<br>|
| Experimental: 3<br>150 μL intradermal injection of 30 μmol/L AZD3161 | Drug: AZD3161<br>* Single dose, intradermal injection<br>|
| Active Comparator: 4<br>150 μL intradermal injection of 10 mg/mL Lidocaine | Drug: Lidocaine<br>* Single dose, intradermal injection<br>|
| Placebo Comparator: 5<br>150 μL intradermal injection of AZD3161 placebo | Drug: AZD3161 Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of mechanical pain testing using Quantitative Sensory Testing |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events |  | Range of 14 days | 
| Vital signs | (blood pressure, heart rate, pulse) | Day 1 | 
| Clinical chemistry (urinalysis, hematology) |  | At follow up (a range of 8-15 days after Day 1) | 
| The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allodynia, hyperalgesia, paresthesia