Actively Recruiting
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
Led by iN Therapeutics Co., Ltd. · Updated on 2024-06-24
64
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative bioavailability of Mesylate vs Hydrochloride salt capsules of iN1011-N17 in Healthy volunteers.
CONDITIONS
Official Title
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years at consent
- Body mass index (BMI) between 18 and 32 kg/m2 and minimum weight of 45 kg for healthy volunteers
- Clinically acceptable pulse rate, respiratory rate, blood pressure, and body temperature at screening and before dosing
- Normal clinical laboratory values at screening and before dosing unless deemed not significant
- Use of effective contraception throughout the study and specified periods after last dose, with specific conditions for males and females
- Cognitively capable and able to comply with study requirements
- Written informed consent
- Willing and able to attend necessary study visits
- Good general health with no significant medical history or examination abnormalities
- Post-herpetic neuralgia patients aged 50 to 75 years at consent
- Clinically acceptable vital signs and body temperature for PHN patients
- BMI between 18 and 40 kg/m2 and minimum weight of 45 kg for PHN patients
- Diagnosis of neuropathic pain from PHN lasting more than 3 months after rash healing
- Douleur Neuropathique 4 (DN4) score of 4 or higher at screening
You will not qualify if you...
- History or presence of carcinoma, liver, kidney, neurological, lung (except childhood asthma), endocrine, blood, heart, or urinary diseases that may affect safety or study evaluation
- Physical or psychiatric conditions that may affect compliance
- History of gastrointestinal diseases or surgeries affecting safety or drug assessment
- Central nervous system diseases affecting safety or drug assessment
- Herniated disc or related diseases affecting safety or drug assessment
- History of hypersensitivity to iN1011-N17 or its components
- Allergies or sensitivities to sulfonamides or other specified allergens without prior approval
- Abnormal 12-lead ECG findings deemed clinically significant
- Positive tests for hepatitis B, hepatitis C, or HIV
- Positive urine drug or alcohol breath tests at screening
- Certain laboratory abnormalities within 14 days before first treatment
- Use of prescription or over-the-counter drugs, herbal remedies, or supplements without prior approval before dosing
- Use of investigational drugs or devices within 30 days before screening
- Blood or plasma donation exceeding 450 mL within 90 days before dosing
- History of significant alcohol or substance abuse
- Use of more than 5 nicotine products per week within 90 days before screening
- Consumption of certain fruits and caffeine restricted before and during study periods
- Unwillingness to avoid strenuous exercise before and during study
- Any other condition affecting safety or study assessment as judged by the investigator
- Previous participation or withdrawal from this or related studies
- Recent vaccination within specified timeframes before baseline
- High pain scores or other severe pain conditions unrelated to PHN
- Inability or unwillingness to stop pain medications or prohibited medications during study
- Prior use of investigational product or drug/device within 30 days or five half-lives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
Y
Yeseul Shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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