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Indetek's IDT-003 Gel Phase I Clinical Trial Officially Kicked-off and Low Dose Group Subjects Enrolment Completed
Time:2024-12-10
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Recently, the Phase I clinical trial of Indetek's IDT-003 gel was successfully kicked-off and the enrolment of the low-dose group participants was completed at the Hospital of Skin Disease, the Chinese Academy of Medical Sciences. IDT-003 gel is developed based on Indetek's proprietary ILDS® transdermal drug delivery technology platform and is indicated for the treatment of melasma. The Phase I clinical trial will use a randomized, placebo-controlled, double-blind, open-label, positive drug control, multiple dose escalation design to evaluate the safety, tolerability and pharmacokinetic characteristics of IDT-003 gel in healthy subjects aged 18 to 50 years (Protocol Number: IDT-003-CLN-01). Full enrolment and follow-up visits of this Phase I clinical trial is expected to be completed within three months.

IDT-003 gel received clinical trial approval from the Center for Drug Evaluation (CDE), NMPA on 23 September. It is the first topical melasma treatment to receive clinical trial approval in China. The administration of the drug to subjects in the low-dose group marks another significant milestone for IDT-003.

Project Kick-off Meeting of IDT-003 Gel at the Hospital of Skin Disease, the Chinese Academy of Medical Sciences.

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