A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects

NCT05525468 | Completed Phase 1 FDA Drug

• 1 other identifier: 239-13851-101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Incidence (severity and causality) of any local and systemic AEs

  Collection of adverse events

  42 days

• Number of subjects with presence (and severity) of local skin reactions (LSRs)

  Collection of LSRs

  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

  3 days

• Changes from baseline in vital signs-MAD group

  Collection of vital signs on day 1, day 7, and day 28

  28 days

• Changes from baseline in laboratory test results-SAD group

  Collection of safety labs on day 1, day 2 and day 3

  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

  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

  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)

  28 days

Secondary Outcomes (1)

• Plasma concentrations of TDM-180935

  29 days

Study Arms (4)

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%

Drug: TDM-180935

SAD placebo for TDM-180935 topical ointment

PLACEBO COMPARATOR

Single dose administration of placebo for TDM-180935 topic ointment

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%

Drug: TDM-180935

MAD placebo for TDM-180935 topical ointment

PLACEBO COMPARATOR

Multiple dose administration of placebo for TDM-180935 topic ointment

Drug: Placebo

Interventions

TDM-180935 DRUG

TDM-180935 topical ointment

MAD Cohorts 1-4 TDM-180935 topical ointment; SAD Cohorts 1-4 TDM-180935 topical ointment

Placebo DRUG

Placebo for TDM-180935 topical ointment

MAD placebo for TDM-180935 topical ointment; SAD placebo for TDM-180935 topical ointment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
• 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).

Sponsors & Collaborators

• Technoderma Medicines Inc.: lead
• Therapeutics, Inc.: collaborator

Study Sites (1)

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Study Officials

• Daniel J. Piacquadio, M.D.

  Therapeutics Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 1, 2022
• Study Start: February 8, 2023
• Primary Completion: August 18, 2023
• Study Completion: October 13, 2023
• Last Updated: November 18, 2023

Record last verified: 2022-08

Locations

US (1)