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Also known as SHP639 (n=60)
SHP639 · 1 trial · 2 indications
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.
| Arm | Type | Description |
|---|---|---|
| SHP639 Ophthalmic Solution Arm (n=60) | EXPERIMENTAL | Participants are divided into groups called cohorts. There will be approximately 12 cohorts, each consisting of 7 participants. In each cohort 5 out of 7 participants will be assigned a specified concentration of SHP639 (0.1%, 0.3%, or 0.6%) ophthalmic solution and a specific dosing schedule (the study participants will be instructed to insill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Vehicle Ophthalmic Arm (n=24) | PLACEBO_COMPARATOR | In each cohort 2 out of 7 participants will be assigned a placebo ophthalmic solution matched to 0.1%, 0.3%, and 0.6% SHP639 ophthalmic solution and specific dosing schedule (the study participants will be instructed to instill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Name | Type | Description |
|---|---|---|
| SHP639 (n=60) | DRUG | Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog. |
| Placebo Comparator (n=24) | DRUG | Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product. |
Inclusion Criteria: 1. Participants must provide written, signed and dated informed consent to participate in the study in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing any study-related ...
SHP639 is an investigational small molecule eye drop being studied for Primary Open-angle Glaucoma (POAG) and ocular hypertension, a condition of high eye pressure. It was evaluated in a Phase 1 clinical trial in adults aged 18 years and older. SHP639 is not yet approved for any indication.
SHP639 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 study of SHP639 eye drops in adults with high eye pressure or Primary Open-angle Glaucoma conducted in the United States.
SHP639 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was randomized, double-blind, and placebo-controlled, enrolling 63 participants with Primary Open-angle Glaucoma or ocular hypertension.
SHP639 has been studied in one completed Phase 1 trial, NCT03131167, titled Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma. The trial enrolled 63 adults aged 18 years and older in the United States and included participants of all sexes.
Yes, SHP639 (n=60) refers to the same investigational compound as SHP639. The parenthetical notation reflects the trial enrollment size. SHP639 is a small molecule eye drop developed by Takeda for Primary Open-angle Glaucoma and ocular hypertension.