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Other

TDM-180935 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Technoderma Medicines Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Study Summary

This trial tested a new topical drug on healthy male volunteers to see if it was safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in ECG readings-MAD group
Changes from baseline in ECG readings-SAD group
Changes from baseline in laboratory test results-MAD group
+5 more
Secondary outcome measures
Plasma concentrations of TDM-180935

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 1-4 TDM-180935 topical ointmentExperimental Treatment1 Intervention
Single dose administration of TDM-180935 topic ointment, 0.25% or 0.5% or 1.0% or 2.0%
Group II: MAD Cohorts 1-4 TDM-180935 topical ointmentExperimental Treatment1 Intervention
Multiple dose administration of TDM-180935 topic ointment, 0.25% or 0.5% or 1.0% or 2.0%
Group III: SAD placebo for TDM-180935 topical ointmentPlacebo Group1 Intervention
Single dose administration of placebo for TDM-180935 topic ointment
Group IV: MAD placebo for TDM-180935 topical ointmentPlacebo Group1 Intervention
Multiple dose administration of placebo for TDM-180935 topic ointment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TDM-180935
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Technoderma Medicines Inc.Lead Sponsor
4 Previous Clinical Trials
157 Total Patients Enrolled
Therapeutics, Inc.Industry Sponsor
30 Previous Clinical Trials
3,854 Total Patients Enrolled
Daniel J. Piacquadio, M.D.Study DirectorTherapeutics Incorporated
2 Previous Clinical Trials
95 Total Patients Enrolled

Media Library

TDM-180935 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05525468 — Phase 1
Healthy Subjects Research Study Groups: MAD Cohorts 1-4 TDM-180935 topical ointment, SAD Cohorts 1-4 TDM-180935 topical ointment, SAD placebo for TDM-180935 topical ointment, MAD placebo for TDM-180935 topical ointment
Healthy Subjects Clinical Trial 2023: TDM-180935 Highlights & Side Effects. Trial Name: NCT05525468 — Phase 1
TDM-180935 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525468 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this investigation?

"Eligibility for this study necessitates that participants are of sound health and in the age bracket spanning 18 to 55 years old. Approximately 56 individuals will be accepted into the trial."

Answered by AI

Is eligibility for this research trial limited to those younger than fifty years old?

"The parameters for this trial restrict recruitment to participants that are between 18 and 55 years old. Separately, there is a cohort of 550 trials for minors and 367 studies for elderly individuals."

Answered by AI

Is the FDA sanctioning utilization of SAD Cohorts 1-4 TDM-180935 topical ointment?

"Since only preliminary data is available concerning the safety and efficacy of SAD Cohorts 1-4 TDM-180935 topical ointment, it was assigned a score of one."

Answered by AI

Is access to this clinical trial currently available for individuals seeking care?

"Affirmative. Clinicaltrials.gov has proof that this clinical trial is recruiting patients at the moment, with its original posting being dated February 8th 2023 and last edit on April 16th 2023. 56 participants are required from 1 medical centre to participate in the study."

Answered by AI

How many participants are engaged in this research endeavor?

"Affirmative. Clinicaltrials.gov attests that this medical investigation is currently accepting participants, which was first posted on February 8th 2023 and recently updated April 16th 2023; the study requires 56 individuals from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects
2023. "A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525468.
~27 spots leftby Apr 2025
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