A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Subject age between 18 to 55 years old.

• Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.

• Subject is able to complete the clinical study including the follow-up.

• Subject is capable of providing written informed consent.

Locations
Other Locations
Malaysia
Hospital Ampang
RECRUITING
Ampang
Contact Information
Primary
David Xu, Director of Clinical Department, MD, PhD
David.Xu@coriumintl.com
1-616-8982176
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2025-04-16
Participants
Target number of participants: 24
Treatments
4 groups subjects will be recruited. Each group will be composed of 6 subjects, sex ratio 1:1
Group1, 2,3 will be administered with 3 different patches (TDS) once for a week, respectively; Group 4 will be oral administered with one capsule (0.92 mg) only.
Sponsors
Leads: Corium Innovations, Inc.

This content was sourced from clinicaltrials.gov