HealthyPhase 1NCT05525468
A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects
A Phase 1 study testing TDM-180935 in people with Healthy, run by Technoderma Medicines Inc. at 1 site in United States.
Trial summary
Multi-center, randomized, double-blind, vehicle-controlled, parallel group, dose escalation study of TDM-180935 following topical administration in healthy male subjects, 18 to 55 years old Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TDM-180935
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 13 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To enter the study, a subject must meet the following criteria:
- Subject is a male, 18-55 years old at Visit1/Screening.
- Subject has provided written informed consent.
- Subject is willing and able to apply the IP(s) as directed, comply with study instructions (including avoiding direct sunlight exposure to the areas of IP application), and commit to all follow-up visits for the duration of the study.
- Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation or exposes the subject to an unacceptable risk by study participation.
- Subject has normal renal and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
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- Subject is a non-smoker, defined as not having smoked or used any form of tobacco or non-tobacco products containing nicotine in more than 6 months before Visit 2/Baseline.
- Subject has a body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg at Visit 1/Screening.
- Subject agrees to continue his other general skin care products and regimen for at least 2 weeks prior to Visit 2/Baseline, and through the entire study.
- Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least 6 months prior to treatment) must agree to refrain from sperm donation for at least 90 days after application of their last dose of IP and inform their non-pregnant female sexual partner to use a highly effective method of birth control as described in the informed consent form. Note: Male subject must verbally confirm that any female partner(s) must be non-pregnant at Visit 1/Screening and Visit 2/Baseline or at the visit when a subject identifies a new sexual partner.
Who cannot join
- A subject is ineligible to enter the study if he/she meets 1 or more of the following criteria:
- Subject has any dermatological disorders of the skin within 20 cm of the Treatment Areas with the possibility of interfering with the application of the IP or examination method, such as fungal or bacterial infections, psoriasis, eczema, folliculitis, notable scarring (linear scar > 2.5 cm, etc.), or skin atrophy at Visit 2/Baseline.
- Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the IP or requires use of interfering topical, systemic, or surgical therapy at Visit 2/Baseline.
- Subject has any visible inflammatory skin disease, injury, or condition of their skin that could compromise subject safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
- Subject has a known or suspected malignancy at Visit 2/Baseline excluding basal cell skin cancer unless it is associated with the Treatment Areas per Exclusion Criterion #1.
- Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
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- Subject has any condition, which, in the investigator's opinion, would make it unsafe for the subject to participate in this study, including clinically significant abnormal laboratory, or 12-lead electrocardiogram (ECG) findings during the screening period or Visit 2/Baseline prior to dosing of the IP.
- Subject has a hospital admission or major surgery within 30 days prior to Visit 2/ Baseline or planned for during the study.
- Subject is currently enrolled in an investigational drug, biologic, or device study.
- Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives, whichever is longer, prior to Visit 2/Baseline.
- Subject has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening.
- Subject has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening.
- Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or Visit 2/Baseline.
- Subject has a donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to Visit 2/Baseline.
- Subject has used systemic prescription medications, herbal (including St John's Wort, herbal teas and garlic extracts) supplements within 14 days prior to dosing at Visit 2/Baseline.
- Subject has used systemic over-the-counter (OTC) medications or vitamins within 7 days prior to dosing at Visit 2/Baseline. (Note: Use of acetaminophen at < 3g/day is permitted until 24 hours prior to dosing at Visit 2/Baseline).
- Subject has used topical cosmetic (excluding bland moisturizers), herbal, OTC or prescription products within the designated Treatment Areas 1 day prior to dosing at Visit 2/Baseline.
- Subject received a live or live attenuated vaccine within 4 weeks of dosing at Visit 2/Baseline.
- Subject has signs or symptoms consistent with COVID-19 at Visit 1/Screening or Visit 2/Baseline or has been diagnosed with COVID-19 within 4 weeks of Visit 1/Screening.
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject has previously been treated with the IP.
- Subject has a history of sensitivity to any of the ingredients in the IP.
- Subject has ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the investigator's opinion, should exclude participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects
Multi-center, randomized, double-blind, vehicle-controlled, parallel group, dose escalation study of TDM-180935 following topical administration in healthy male subjects, 18 to 55 years old
Read the detailed description
Protocol 239-13851-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects". Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo vs. placebo/placebo). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.
- Conditions
- Healthy
- Being tested
- TDM-180935, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDM-180935Drug
TDM-180935 topical ointment
PlaceboDrug
Placebo for TDM-180935 topical ointment
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1-4 TDM-180935 topical ointment | Experimental | Single dose administration of TDM-180935 topic ointment, 0.25% or 0.5% or 1.0% or 2.0% Receives: Drug: TDM-180935 |
| SAD placebo for TDM-180935 topical ointment | Placebo comparator | Single dose administration of placebo for TDM-180935 topic ointment Receives: Drug: Placebo |
| MAD Cohorts 1-4 TDM-180935 topical ointment | Experimental | Multiple dose administration of TDM-180935 topic ointment, 0.25% or 0.5% or 1.0% or 2.0% Receives: Drug: TDM-180935 |
| MAD placebo for TDM-180935 topical ointment | Placebo comparator | Multiple dose administration of placebo for TDM-180935 topic ointment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (severity and causality) of any local and systemic AEs
Collection of adverse events
Measured: 42 days
Number of subjects with presence (and severity) of local skin reactions (LSRs)
Collection of LSRs
Measured: 42 days
Changes from baseline in vital signs-SAD group
Collection of vital signs on day 1 (pre-dose and 6 hrs post-dose) and day 3
Measured: 3 days
Changes from baseline in vital signs-MAD group
Collection of vital signs on day 1, day 7, and day 28
Measured: 28 days
Changes from baseline in laboratory test results-SAD group
Collection of safety labs on day 1, day 2 and day 3
Measured: 3 days
Changes from baseline in laboratory test results-MAD group
Collection of safety labs on day 1, day 7, day 14, and day 28
Measured: 28 days
Changes from baseline in ECG readings-SAD group
Collection of ECGs on day 1 (pre-dose and 6 hrs post-dose) and day 3
Measured: 3 days
Changes from baseline in ECG readings-MAD group
Collection of ECGs on day 1, day 7, and day 28 (pre-dose and 6 hrs post-dose)
Measured: 28 days
Secondary outcomes (1)
Plasma concentrations of TDM-180935
Plasma concentrations of TDM-180935
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start8 Feb 2023
- Primary completion18 Aug 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technoderma Medicines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel J. Piacquadio, M.D., Study director, Therapeutics Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525468
- Sponsor's protocol ID
- 239-13851-101
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05525468
- Acronym / sponsor ID
- 239-13851-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Technoderma Medicines Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, randomized, double-blind, vehicle-controlled, parallel group, dose escalation study of TDM-180935 following topical administration in healthy male subjects, 18 to 55 years old
Detailed description
Protocol 239-13851-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects". Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo vs. placebo/placebo). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1-4 TDM-180935 topical ointment | Experimental | Drug: TDM-180935Single dose administration of TDM-180935 topic ointment, 0.25% or 0.5% or 1.0% or 2.0% |
| SAD placebo for TDM-180935 topical ointment | Placebo comparator | Drug: PlaceboSingle dose administration of placebo for TDM-180935 topic ointment |
| MAD Cohorts 1-4 TDM-180935 topical ointment | Experimental | Drug: TDM-180935Multiple dose administration of TDM-180935 topic ointment, 0.25% or 0.5% or 1.0% or 2.0% |
| MAD placebo for TDM-180935 topical ointment | Placebo comparator | Drug: PlaceboMultiple dose administration of placebo for TDM-180935 topic ointment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject is a male, 18-55 years old at Visit1/Screening.
- Subject has provided written informed consent.
- Subject is willing and able to apply the IP(s) as directed, comply with study instructions (including avoiding direct sunlight exposure to the areas of IP application), and commit to all follow-up visits for the duration of the study.
- Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation or exposes the subject to an unacceptable risk by study participation.
- Subject has normal renal and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
Key exclusion criteria (23 listed)
- A subject is ineligible to enter the study if he/she meets 1 or more of the following criteria:
- Subject has any dermatological disorders of the skin within 20 cm of the Treatment Areas with the possibility of interfering with the application of the IP or examination method, such as fungal or bacterial infections, psoriasis, eczema, folliculitis, notable scarring (linear scar > 2.5 cm, etc.), or skin atrophy at Visit 2/Baseline.
- Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the IP or requires use of interfering topical, systemic, or surgical therapy at Visit 2/Baseline.
- Subject has any visible inflammatory skin disease, injury, or condition of their skin that could compromise subject safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
- Subject has a known or suspected malignancy at Visit 2/Baseline excluding basal cell skin cancer unless it is associated with the Treatment Areas per Exclusion Criterion #1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDM-180935TDM-180935 topical ointment | Drug | MAD Cohorts 1-4 TDM-180935 topical ointment, SAD Cohorts 1-4 TDM-180935 topical ointment |
| PlaceboPlacebo for TDM-180935 topical ointment | Drug | MAD placebo for TDM-180935 topical ointment, SAD placebo for TDM-180935 topical ointment |
Primary outcome
Incidence (severity and causality) of any local and systemic AEs
Time frame: 42 days
Collection of adverse events
Number of subjects with presence (and severity) of local skin reactions (LSRs)
Time frame: 42 days
Collection of LSRs
Changes from baseline in vital signs-SAD group
Time frame: 3 days
Collection of vital signs on day 1 (pre-dose and 6 hrs post-dose) and day 3
Changes from baseline in vital signs-MAD group
Time frame: 28 days
Collection of vital signs on day 1, day 7, and day 28
Changes from baseline in laboratory test results-SAD group
Time frame: 3 days
Collection of safety labs on day 1, day 2 and day 3
Changes from baseline in laboratory test results-MAD group
Time frame: 28 days
Collection of safety labs on day 1, day 7, day 14, and day 28
Changes from baseline in ECG readings-SAD group
Time frame: 3 days
Collection of ECGs on day 1 (pre-dose and 6 hrs post-dose) and day 3
Changes from baseline in ECG readings-MAD group
Time frame: 28 days
Collection of ECGs on day 1, day 7, and day 28 (pre-dose and 6 hrs post-dose)
1 secondary outcome
Plasma concentrations of TDM-180935
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J. Piacquadio, M.D. study director
Therapeutics Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TDM-180935 in people with Healthy, run by Technoderma Medicines Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (severity and causality) of any local and systemic AEs (time frame: 42 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.