A Randomized, Double-blind, Placebo-controlled, Multiple-Ascending Dose Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/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 in Healthy Volunteers

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

‣ Healthy Volunteers

• Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of consent.

• Body mass index (BMI = body weight (kg)/\[height (m)\]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).

• Clinically acceptable pulse rate, RR, and tympanic body temperature (pulse rate between 45 and 100 beats per minute \[bpm\]; SBP between 90 and 140 mmHg; DBP between 50 and 90 mmHg; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C at Screening and Day -1). Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position

• For Healthy Volunteers and Post-Herpetic Neuralgia Patients

• Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator.

• All participants (excluding those who are exclusively in same-sex relationships, who are postmenopausal or have an exclusive partner who is postmenopausal) must agree to use a highly effective method of contraception throughout the study and for at least 30 days for females or 90 days for males after the last dose of IP. Female participants must not be breastfeeding, lactating, or pregnant during the study period.

• Female participants are required to be on their chosen contraceptive for at least 7 days before dosing.

• Female participants, where their sole, male sexual partner is vasectomized, must provide a verbal confirmation of azoospermia (90 days following the procedure) which should be recorded in the source documents by the Investigator.

• The minimum timeframe for pre-dose vasectomy for male participants is ≥ 12 weeks, unless they are the sole sexual partner of a female participant as outlined above.

• Male participants who are sexually active must use a condom combined with use of a highly-effective method of contraception for the female partner (excluding those who have had a vasectomy or whose partner is postmenopausal). Confirmation of the female partner's contraceptive information must be provided verbally by the male participant and should be recorded in the source documents by the Investigator. The postmenopausal status of the female partner must be confirmed verbally by the male participant and should be recorded in the source documents by the Investigator.

• Cognitively capable of understanding the provided information and able to fully comply with protocol requirements.

• Written informed consent prior to the commencement of any study procedures.

• Willing and able to perform the necessary visits to the investigational site/institution.

• In good general health at the Investigator's discretion, with no significant medical history, and with no clinically significant abnormalities on physical examination at Screening and before the first dose of IP.

• Post-Herpetic Neuralgia Patients

⁃ Male and female adults aged 50 to 75 years of age (inclusive) at the time of consent.

⁃ Clinically acceptable blood pressure (BP), pulse rate, RR, and tympanic body temperature (SBP between 90 and 140 mmHg; DBP between 50 and 95 mmHg; pulse rate between 45 and 100 bpm; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C) at Screening and Day -1. Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position.

⁃ BMI (body weight (kg)/\[height (m)\]2) between 18 kg/m2 and 40 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).

⁃ A diagnosis of neuropathic pain of PHN is confirmed when the pain for \>3 months after the herpes zoster rash is healed, with the pain area of a continuous area of affected rash.

⁃ Douleur Neuropathique 4 (DN4) score ≥4 at Screening.

Locations
Other Locations
Australia
CMAX Clinical Research
RECRUITING
Adelaide
Contact Information
Primary
Yeseul Shin
hangsu1208@intherapeutics.com
+82313328425
Time Frame
Start Date: 2022-11-11
Estimated Completion Date: 2024-07-29
Participants
Target number of participants: 64
Treatments
Experimental: iN1011-N17 HCl Suspension (Part 1)
Oral, Preformulation Suspension, b.i.d, Multiple Ascending Dose (Day 1\~ Day7)~Part 1:~Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning.
Experimental: iN1011-N17 HCl Capsule (Part 1)
Oral, Nano Suspension Powder Capsule, b.i.d, Multiple Ascending Dose (Day 1\~ Day7)~Part 1:~Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning.
Placebo_comparator: Placebo Capsule (Part 1)
Oral, Placebo capsule, b.i.d, Multiple Ascending Dose (Day 1\~ Day7)~Part 1:~Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning.
Experimental: iN1011-N17 HCl Capsule (Part 2)
Oral, Nano Suspension Powder Capsule, Single dose~Part 2:~2-period, randomized, open-label, crossover bioavailability part. Participants will receive a single oral dose of each study treatment (HCl salt and Mesylate salt), one during each of the 2 inpatient periods, in a randomized sequence of administration. There will be a minimum washout period of 5 days between each dose of study treatment.
Active_comparator: iN1011-N17 Mesylate Capsule (Part 2)
Oral, AA10 Capsule, Single dose~Part 2:~2-period, randomized, open-label, crossover bioavailability part. Participants will receive a single oral dose of each study treatment (HCl salt and Mesylate salt), one during each of the 2 inpatient periods, in a randomized sequence of administration. There will be a minimum washout period of 5 days between each dose of study treatment.
Experimental: iN1011-N17 HCl Capsule (Part 3)
Oral, Nano Suspension Powder Capsule, b.i.d, Multiple dose (Day 1\~ Day7)~Part 3:~2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo.~Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning.
Placebo_comparator: iN1011-N17 Mesylate Capsule (Part 3)
Oral, AA10 Capsule, b.i.d, Multiple dose (Day 1\~ Day14)~Part 3:~2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo.~Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning.
Experimental: Placebo Capsule (Part 3)
Oral, Placebo capsule, b.i.d, Multiple dose (Day 1\~ Day14)~Part 3:~2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo.~Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning.
Sponsors
Leads: iN Therapeutics Co., Ltd.

This content was sourced from clinicaltrials.gov