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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 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.

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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.

Conditions Studied

Diabetic Peripheral Neuropathic Pain

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

FieldValue
Enrollment Target 24 participants
Start Date 2024-05-16
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Zhejiang Hanmai Pharmaceutical Technology Co.

1 total trials

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What the Registry Record Tells You About NCT06361108

The ClinicalTrials.gov registry entry for NCT06361108 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 434-participant average among 7 other Diabetic Peripheral Neuropathic Pain trials with a reported enrollment target (94% lower). The listed sponsor is Zhejiang Hanmai Pharmaceutical Technology Co., which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.