A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of iN1011-N17-02 in Patients with Post herpetic Neuralgia(PHN)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

iN Therapeutics Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

completed 1 Sep 2025

Decision date (initial)

2025-07-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

iN Therapeutics Co., Ltd.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To identify an optimal dose of iN1011-N17-02 based on evaluation of a preliminary efficacy signal for the
treatment of pain in patients with Post-Herpetic Neuralgia (PHN)

Secondary objectives 3

1. To evaluate the safety and tolerability of iN1011-N17-02 compared with placebo for the treatment of pain in patients with PHN
2. To further evaluate iN1011-N17-02 for the treatment of pain in patients with PHN
3. To characterize the pharmacokinetics (PK) following administration of iN1011-N17-02

Conditions and MedDRA coding

Post herpetic Neuralgia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Male or female, aged 19 to 80 years of age (inclusive)
2. 2. Has provided written informed consent for the study
3. 3. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash, and having received treatment for at least 1 month (with supporting documentation such as a referral letter).
4. 4. Average NRS score (on an 11-point scale) for the week prior to baseline is ≥4 and <9, and < 40% reduction at the end of administration compared to before placebo administration (at least 5 days score out of 7 days score entries from day -7 to day -1 are required)
5. 5. Has a body mass index (BMI) between ≥18 kg/m2 and <40 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg.
6. 6. If participant is of childbearing potential, is practicing a highly effective method of birth control throughout the study and for at least 30 days for females and 90 days for males after the last dose of IP. The following are considered highly effective methods of birth control: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation o oral o intravaginal o transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation o oral o injectable o implantable • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomized partner (vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical assessment of the surgical success) • Sexual abstinence, defined as refraining from heterosexual intercourse during study participation, is acceptable if this is the participant’s usual lifestyle; periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhea method are not acceptable methods of contraception Note: A participant is considered to be of childbearing potential if they are postmenarchal and premenopausal, unless surgically sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy). A postmenopausal state is defined as no menses for at least 1 year without an alternative medical cause.
7. 7. Is able to understand all study information provided and is willing to return to the study facility for all visits, including follow-up evaluations.
8. 8. If participant is taking pain medications, ceasing the pain medication is safe and reasonable as assessed by the Investigator, and the participant must be willing to discontinue all non-study pain medications during this study period, except for permitted rescue pain medication for the duration of the study.

Exclusion criteria 17

1. 1. Presence or history of carcinoma, hepatic, renal, neurological, pulmonary (except for childhood asthma), endocrine, hematologic, cardiovascular, or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the IP effects or place the participant at undue risk (except for conditions that are stable on medications).
2. 10. Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening.
3. 11. Has received any IP or investigational medical device within 30 days before Screening, or 5 half-lives of the product, whichever is longer.
4. 2. Presence of any underlying clinically significant physical or psychiatric condition (except for conditions that are stable on medications) that, in the opinion of the Investigator, may affect assessment of safety, efficacy and PK characteristics of the IP.
5. 3. Other severe pain, the presence of other skin diseases, or pain at the site of the rash at Screening or randomization unrelated to PHN, that may confound the assessment of PHN-related pain
6. 4. Have a mean NRS score (on an 11-point scale) for the week prior to baseline visit is <4 or ≥ 9 on the pain assessment at randomization, or ≥ 9 on any day out of pre-randomization pain assessment period (PPAP).
7. 5. Participant is currently undergoing antiviral treatment for Herpes Zoster.
8. 6. Participant is pregnant, lactating, or with a positive pregnancy test result at Screening
9. 7. Participant has known allergy or significant adverse reaction to iN1011-N17- 02 or to any of its components.
10. 8. History of allergy or sensitivity to sulfonamides, hay fever, asthma, eczema, food allergies, and/or allergies to other medications. Participants with asymptomatic, untreated, seasonal allergies at the time of dosing may be considered for inclusion on a case-by-case basis. Investigator and iN Therapeutics approval must be obtained prior to randomization.
11. 9. Any abnormal 12-lead ECG findings defined as QTcF > 430 msec, RR interval > 210 msec or QRS interval > 120 msec at Screening and Day 1, deemed to be clinically significant by the Investigator or designee
12. 12. Previous use of neurolytic block or neurosurgical therapy for current PHN; a. Any history of chemical neurolytic block using phenol or ethyl alcohol b. History of neurolytic block using local anesthetics within 2 weeks before screening c. History of radiofrequency thermocoagulation or any radiofrequency related therapy within 6 months before screening
13. 13. Blood or plasma donation of more than 450 mL within 90 days before the first dose of IP and for the duration of the study. It is recommended that blood/plasma donations not be made for at least 30 days after study completion.
14. 14. Any of the following laboratory abnormalities at Screening: a. Platelet count < 100,000 cells/mm3 b. Total neutrophil count < 1500 cells/mm3 c. Alanine aminotransferase (ALT) > 2.0× upper limit of normal (ULN) d. Aspartate aminotransferase (AST) > 2.0 × ULN e. Alkaline phosphatase > 1.5 × ULN f. Bilirubin > 1.5 × ULN g. Temperature ≥ 38°C or any other evidence of an infection h. Serum potassium <3.5 mmol/L i. Creatinine clearance <60 mL/min j. Fasting triglycerides >250 mg/dL k. HbA1c >10%
15. 15. Positive urine drug screen test result (including methamphetamines, opiates, cocaine, cannabinoids, phencyclidine, barbiturates, methadone and amphetamines) or positive alcohol breath test result at Screening or Day 1 (pre-dose). Repeated tests will be allowed at the discretion of the Investigator for suspected false positives.
16. 16. History of alcoholism, substance or drug abuse-related disorders deemed significant by the Investigator (or designee) within 1 year before screening.
17. 17. Use of the following prohibited medication within PPAP 7 days, or started taking or has changed the dosage of prohibited concomitant medications within 7 days prior to screening.: Gabapentinoids, NSAIDs, steroids, local anesthetics, opioid analgesics (permitted for the second-line rescue medication (acetaminophen/ tramadol hydrochloride combination medication)), antidepressants, Anxiolytics, Hypnotics, Sedative, anticonvulsants, muscle relaxants, immunosuppressants, potassium/licorice-containing agents, glycyrrhizic acid, thiazide diuretics, loop diuretics, prostaglandin and related products, neurotrophin, nefopam, topical capsaicin, central-acting sympatholytics, Na channel blocker, NMDA antagonists, vitamins B1 and B12, α-lipoic acid or γ-linolenic acid However, participation is allowed after washout in accordance with the halflife of each of the medications. If participant is taking hypnotics or antidepressants for the purpose of treating underlying diseases, etc., if there is no change in dosage from 14 days before the first administration of the investigational product, concurrent use is permitted at the discretion of the investigator. No changes in medication or dosage are permitted during the study period, and changes in dosage or discontinuation of the drug are permitted as needed only if any safety issue is observed..

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The mean change from Baseline to the last week of treatment (Week 4) in the average weekly numeric rating scale (NRS) pain score

Secondary endpoints 17

1. Incidence, severity, and causality of adverse events (AEs) and serious AEs (SAEs)
2. Abnormalities in the following: o Physical examination o Vital signs (pulse rate, systolic/diastolic blood pressure, respiratory rate, and tympanic temperature) o 12-lead electrocardiogram (ECG) o Laboratory tests (hematology, urinalysis, and serum chemistry)
3. Daily pain intensity assessed by NRS pain score
4. Score of Short Form McGill Pain Questionnaire (SF-MPQ-2
5. Score of Brief Pain Inventory-Short Form (BPI-SF)
6. Change in average weekly NRS pain score from Baseline to Weeks 1, 2, and 3
7. Change from Baseline over time in individual parameters assessed using SF MPQ-2
8. The percentage of responders defined as participants with a ≥ 30% and ≥ 50% reduction in their NRS pain score from Baseline to Week 4
9. Percentage of participants with much improved or very much improved change in pain according to Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) at Week 4
10. Change from Baseline to Week 4 in Pain Quality Assessment Scale (PQAS) score
11. Rescue medication consumption (dose, frequency
12. Change from Baseline to Week 4 in BPI-SF score, pain interference subscale
13. Change from Baseline to Week 4 in Daily Sleep Interference Scale (DSIS)
14. The following PK parameters will be evaluated at Day 1 (pre-dose and post-dose after single dose, 0 3 hours): o Maximum plasma concentration (Cmax) o Time to maximum plasma concentration (Tmax) o Area under the plasma concentration curve over the twice daily (bid) dosing interval (AUC0-3)
15. The following PK urine parameters will be evaluated on Day 1 (0 3 hours): o Fraction excreted unchanged in urine, from time 0 to 3 hours (fe,0-3) o Amount of investigational product (IP) excreted unchanged in the urine, from time 0 to 3 hours (Ae,0-3) o Renal clearance (CLR)
16. The following PK parameters will be evaluated at steady state at Week 4 on the last day of dosing: oPlasma IP concentration pre-dose (C0) oMaximum steady-state plasma IP concentration during a dosage interval (Cmax,ss) oMinimum steady-state plasma IP concentration during a dosage interval (Cmin) oTime to reach maximum (peak) plasma concentration following IP administration at steady-state (Tmax,ss) oArea under the plasma concentration-time curve, from time 0 (pre-dose) to 3 hours postdose(AUC0-3
17. The following urine PK parameters will be evaluated at steady-state at Week 4 on the last day of dosing: o Fe0-3,ss o Ae0-3,ss o CLR

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

iN Therapeutics Co. Ltd.

Sponsor organisation

iN Therapeutics Co. Ltd.

Address

501-6 Samgye-Ri, Pogok-Eup, Cheoin-Gu Pogok-Eup Cheoin-Gu

City

Yongin-Si

Postcode

17028

Country

Korea, Republic of

Scientific contact point

Organisation

iN Therapeutics Co. Ltd.

Contact name

Clinical Project manager

Public contact point

Organisation

iN Therapeutics Co. Ltd.

Contact name

Clinical Project manager

Third parties 4

Locations

2 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications