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NCT06361108 · ClinicalTrials.gov registry record · Phase 1
MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
A Phase 1 study of Diabetic Peripheral Neuropathic Pain, sponsored by Zhejiang Hanmai Pharmaceutical Technology Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06361108: Recruiting Phase 1 study of Diabetic Peripheral Neuropathic Pain, sponsored by Zhejiang Hanmai Pharmaceutical Technology Co..
NCT06361108 is a Phase 1 study of Diabetic Peripheral Neuropathic Pain that is actively recruiting participants, run by Zhejiang Hanmai Pharmaceutical Technology Co.. The registered enrollment target is 24 participants, below the 434-participant average among 7 other Diabetic Peripheral Neuropathic Pain trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06361108, a Phase 1 study of Diabetic Peripheral Neuropathic Pain, is actively recruiting participants, sponsored by Zhejiang Hanmai Pharmaceutical Technology Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center. In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects. Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11.
Primary Outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Conditions Studied
Interventions
- DRUG YJ001 for Spray Use
- DRUG Placebo of YJ001 for Spray Use
Study Locations (1)
Texas
- Clinical Trials of Texas,LLC - Fredericksburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT06361108 shows while recruiting
NCT06361108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 434-participant average among 7 other Diabetic Peripheral Neuropathic Pain trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Diabetic Peripheral Neuropathic Pain appearing as the primary indexed condition, and to 2 interventions - of which YJ001 for Spray Use is the first listed.
NCT06361108 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06361108 about?
NCT06361108 is a clinical study titled "MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP". This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single ...
What is the current status of trial NCT06361108?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-05-16. Estimated completion is 2026-06-30.
What conditions does trial NCT06361108 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathic Pain.
What interventions are being tested in trial NCT06361108?
The interventions under investigation include: YJ001 for Spray Use (DRUG), Placebo of YJ001 for Spray Use (DRUG).
Who is sponsoring clinical trial NCT06361108?
This trial is sponsored by Zhejiang Hanmai Pharmaceutical Technology Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06361108 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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