A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.

NCT07599800 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Andros-APC101-301
• Study Type: interventional
• Target: 333
• Locations: 2 countries
• Sites: 2

Brief Summary

APC101 is developed to provide continuous lidocaine administration over 24 hours and is safe when administered to intact skin. Dispensing from a metered-dose spray pump, APC101 provides once or twice daily flexible dosing options that deliver medication without physically touching the afflicted allodynic skin site, resulting in very light, minimal contact with the painful, hypersensitive skin affected by PHN.

Conditions

PHN - Post-Herpetic Neuritis

Keywords

PHN; APC101

Outcome Measures

Primary Outcomes (1)

• NRS-11

  Change in the weekly average pain score\* (WAPS), assessed using NRS-11.

  From baseline (Week -1; within 7 days ending on the date of randomization) to the evaluation conducted within 7 days ending on the date of the end of treatment (EOT).

Study Arms (2)

APC101

EXPERIMENTAL

Lidocaine spray 5% solution

Drug: APC101

Control

PLACEBO COMPARATOR

Vehicle spray solution

Other: Control

Interventions

APC101 DRUG

Lidocaine spray 5% solution

APC101

Control OTHER

A vehicle spray solution

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males or females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years.
• Female of non-childbearing potential (i.e., 12 months or more of spontaneous amenorrhea without an alternative medical cause, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization,.
• Women of childbearing potential (WOCBP) must be confirmed to be not pregnant at Screening Visit.
• Males with sexual partners and females of childbearing potential must agree to use a highly effective contraceptive method:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• Oral
• Intravaginal
• Transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:
• Oral
• Injectable
• Implantable
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion

You may not qualify if:

• Participant has systemic disease that would put him/her at an additional risk or limit his/her ability to participate in the study as judged by the investigator.
• Participant has a history of human immunodeficiency virus, hepatitis C, or hepatitis B.
• Participant has a history of malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years.
• Participant has a history of mental illness or psychiatric illness, such as dementia, depression, or schizophrenia, that can limit his/her ability to comply with study procedures as judged by the investigator.
• Participant is unable to apply, or to have a caregiver apply, the study spray to the most painful skin segments twice a day as directed.
• Participant has known sensitivity to lidocaine-containing products.
• Participant has active herpes zoster lesions or dermatitis.
• Participant has other condition(s) that cause severe or chronic pain that may impair the self-assessment of the pain due to PHN as judged by the investigator.
• Participant has been treated in the area of PHN with a local anesthetic within 14 days prior to Run-in period or has had a nerve block within 30 days prior to Run-in period.
• Participant is receiving or plans to receive any prohibited medication or therapy for the duration of the study, or is unable to washout these medications or therapies prior to Run-in period.
• Participant has used capsaicin patches within 90 days prior to Run-in period or has used other capsaicin preparations daily in the 90 days prior to Run-in period.
• Pregnant or lactating females.
• Participant has an active history of alcohol or drug abuse.
• Participant has participated in any other investigational study within 30 days prior to Screening Visit.
• Participant or participant's direct family is employed by the sponsor or study staff.

Sponsors & Collaborators

• Andros Pharmaceuticals Co., Ltd.: lead

Study Sites (2)

Suncoast Clinical Research

Florida City, Florida, 34652, United States

Location

University of Sunshine Cost

Brisbane, Queensland, 4117, Australia

Location

Central Study Contacts

Ae-June Wang, PhD

CONTACT

+886-3-6581866; APC101_P3@andros.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: APC101 or placebo.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

AU (1); US (1)