Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 in Healthy Volunteers and Post-Herpetic Neuralgia Patients
Led by iN Therapeutics Co., Ltd. · Updated on 2024-06-24
64
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.
CONDITIONS
Brief 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 male and female adults aged 18 to 55 years for healthy volunteers and 50 to 75 years for post-herpetic neuralgia patients
- Body mass index (BMI) between 18 and 32 kg/m2 for healthy volunteers and between 18 and 40 kg/m2 for PHN patients, with a minimum weight of 45 kg
- Clinically acceptable pulse rate, respiratory rate, blood pressure, and body temperature at screening and Day -1
- Normal clinical laboratory values unless deemed not clinically significant by the investigator
- Agreement to use highly effective contraception throughout the study and appropriate periods after last dose (30 days for females, 90 days for males), with specific rules for partner status and vasectomy
- Cognitively able to understand study information and comply with protocol
- Written informed consent
- Willingness and ability to attend study visits
- Good general health with no significant medical history or abnormalities at screening and before first dose
- For PHN patients: confirmed neuropathic pain lasting more than 3 months after herpes zoster rash healing
- DN4 score of 4 or higher at screening for PHN patients
You will not qualify if you...
- History or presence of serious diseases including carcinoma, liver, kidney, neurological, lung (except childhood asthma), endocrine, blood, heart, or urinary diseases that may affect safety or evaluation
- Underlying physical or psychiatric conditions that may affect compliance
- History of gastrointestinal diseases or surgeries that affect safety or pharmacokinetics
- Central nervous system diseases affecting safety or pharmacokinetics
- Herniated discs or related diseases affecting safety or pharmacokinetics
- Allergy or hypersensitivity to iN1011-N17 or its components
- Allergy to sulfonamides, hay fever, asthma, eczema, food or medication allergies unless asymptomatic and approved
- Abnormal ECG findings considered clinically significant
- Positive tests for hepatitis B, hepatitis C, or HIV
- Positive drug or alcohol tests at screening and Day -1
- Laboratory abnormalities including low platelets or neutrophils, elevated liver enzymes, bilirubin, or signs of infection
- Use of prescription or over-the-counter medications, supplements, or investigational products before study without approval
- Recent blood or plasma donation exceeding limits
- History of significant alcohol or substance abuse
- Recent use of nicotine products or positive cotinine tests
- Consumption of grapefruit, star fruit, pomelos, caffeine products before dosing
- Unwillingness to refrain from strenuous exercise before and during study
- Previous participation in related studies or receipt of investigational vaccines within specified timeframes
- PHN patients with high pain scores, previous neurolytic or neurosurgical therapies, other severe pain or skin diseases, or inability to stop prohibited medications during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive oral doses of iN1011-N17 or placebo twice daily for 7 days in a multiple ascending dose schedule.
Daily dosing from Day 1 to Day 7 with twice daily doses
Duration - Approximately 2 periods with a minimum 5-day washout
Participants receive a single oral dose of each study treatment (HCl salt and Mesylate salt) during two inpatient periods with a washout period of at least 5 days between doses.
Two inpatient dosing visits with a minimum 5-day washout between doses
Duration - 14 days
Participants receive oral doses of iN1011-N17 or placebo twice daily for 14 days in two cohorts including healthy volunteers and PHN patients.
Twice daily dosing from Day 1 to Day 14
Duration - Up to 21 days after last dose
Participants are monitored after treatment for safety assessments and adverse events.
Follow-up visits for safety monitoring
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
Y
Yeseul Shin
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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