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Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.

NCT06042192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-12

No results posted yet for this study

Summary

This study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.

Conditions

  • Healthy

Interventions

DRUG

TK-254RX

Two TK-254RX per day to predetermined application site

Sponsors & Collaborators

  • ClinSearch

    collaborator OTHER

  • SocraTec R&D GmbH

    collaborator OTHER

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • CRM Biometrics GmbH

    collaborator INDUSTRY

  • Clinigen Clinical Supplies Management GmbH

    collaborator UNKNOWN

  • Teikoku Seiyaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kenichi Nishiyama · Teikoku Seiyaku Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2023-11-09
Completion
2023-12-13
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06042192 on ClinicalTrials.gov