Tetrodotoxin and quantitative sensory testing in healthy volunteers

Evaluation of quantitative sensory testing (QST) Using subcutaneous administration of single escalating doses of Halneuron® (tetrodotoxin (TTX) for injection) in healthy volunteers

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78737401

Enrollment

Registered

2023-09-20

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Signs and Symptoms

Interventions

In this study, two doses of Halneuron (tetrodotoxin) will be administered subcutaneously. During this study, there will be no randomization.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 55 years old (inclusive) 2. Body mass index (BMI) within 19-30 kg/m2 3. Subjects will be healthy according to physical examination (including vital signs) and normal laboratory tests (hematology, biochemistry, urinalysis) including, as well as a negative screening of ethyl alcohol and drugs of abuse in urine.

Exclusion criteria

Exclusion criteria: Not meeting the participant inclusion criteria

Design outcomes

Primary

Measure	Time frame
Sensation and pain thresholds measured using Quantitative Sensory Testing (QST) after two different doses of Halneuron (Tetrodotoxin (TTX) for Injection)	—

Secondary

Measure	Time frame
None provided	—

Countries

Netherlands

Contacts

Public ContactKiki Kuijpers

k.w.k.kuijpers@lumc.nl+31715263537

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026