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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
Summary
This trial tests a new skin-applied medication called TDM-180935. It involves healthy men aged 18-55 to check its safety and how the body handles it. Researchers will observe how the medication is absorbed and any potential side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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: MAD placebo for TDM-180935 topical ointmentPlacebo Group1 Intervention
Multiple dose administration of placebo for TDM-180935 topic ointment
Group IV: SAD placebo for TDM-180935 topical ointmentPlacebo Group1 Intervention
Single 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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have taken any experimental drugs or devices within the last month or 5 half-lives, whichever is longer, before starting the study.You have a history of drinking too much alcohol in the last 6 months before your first screening.You have skin conditions around the treatment areas (within 20 cm) that may interfere with the application of the treatment or examination. These conditions may include fungal or bacterial infections, psoriasis, eczema, notable scarring (linear scar > 2.5 cm, etc.), or skin atrophy.You have a skin condition that could put you at risk or make it difficult for the study team to evaluate your health.You have had an allergic reaction to any of the ingredients in the investigational product.You have already received the investigational product in the past.You have taken prescription medications or herbal supplements within 14 days before the study.You are currently participating in another study that is testing a new drug, biological product, or medical device.You have a history of taking prescription drugs in a way that is not safe or using illegal drugs within the past six months.
Research Study Groups:
This trial has the following groups:- Group 1: SAD Cohorts 1-4 TDM-180935 topical ointment
- Group 2: MAD placebo for TDM-180935 topical ointment
- Group 3: MAD Cohorts 1-4 TDM-180935 topical ointment
- Group 4: SAD placebo for TDM-180935 topical ointment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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