Peripheral KV7 Activation for Pain Relief

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

May 8, 2025

Primary Completion Date

May 28, 2025

Study Completion Date

May 28, 2025

Conditions
Pain
Interventions
DRUG

Capsaicin only (7.6 ng)

Intradermal injection of 7.6 ng capsaicin (0.5 µM, 50 µL) in synthetic interstitial fluid (SIF) without Flupirtine. Used to induce experimental burning pain in the skin.

DRUG

Capsaicin + Flupirtine 0.5 µg

Intradermal co-injection of 7.6 ng capsaicin (0.5 µM) and 0.5 µg Flupirtine in 50 µL SIF. Used to assess local analgesic effect of very low-dose Flupirtine on chemically induced pain.

DRUG

Capsaicin + Flupirtine 1.2 µg

Intradermal co-injection of 7.6 ng capsaicin and 1.2 µg Flupirtine in 50 µL SIF. Part of dose-response evaluation for peripheral pain inhibition.

DRUG

Capsaicin + Flupirtine 3.0 µg

Intradermal co-injection of 7.6 ng capsaicin and 3.0 µg Flupirtine in 50 µL SIF. Intermediate dose in microdose titration series.

DRUG

Capsaicin + Flupirtine 7.6 µg

Intradermal co-injection of 7.6 ng capsaicin and 7.6 µg Flupirtine in 50 µL SIF. This is the highest Flupirtine microdose used in the capsaicin model.

DRUG

Placebo (SIF only, no capsaicin or Flupirtine)

Intradermal injection of 50 µL synthetic interstitial fluid without capsaicin or Flupirtine. Used as negative control for capsaicin-Flupirtine co-injection conditions.

DRUG

Room Temperature Injection (Control)

Intradermal slow infusion of SIF at \~23°C using a programmable pump. No capsaicin or Flupirtine included. Used as baseline control in heat model.

DRUG

Heated injection without Flupirtine

Intradermal slow infusion of synthetic interstitial fluid preheated up to \~52°C. No Flupirtine included. Used to induce thermal pain in human skin.

DRUG

Heated Injection with Flupirtine 124 µg

Intradermal slow infusion of synthetic interstitial fluid up to \~52°C containing 124 µg Flupirtine. Used to test local analgesic effect of high-dose Flupirtine in heat pain model.

Trial Locations (1)

1090

Medical University of Vienna, Vienna

All Listed Sponsors
lead

Stefan Heber

OTHER

NCT06971250 - Peripheral KV7 Activation for Pain Relief | Biotech Hunter | Biotech Hunter