common.study.topics.clinical

Testing Experimental Galactosemia Drug in Healthy Subjects

common.study.values.description

Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia

This study is a first-in-human, randomized, placebo-controlled, 4-Part, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy adult subjects and adult subjects with Classic Galactosemia.

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participant.ui.study.affiliations-map.online-study.header-virtual

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Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - AT-007

AT-007 will be administered once daily before breakfast. Up to 4 different dose cohorts in part A; up to 4 dose cohorts in part B, up to 2 dose cohorts for part C, and up to 3 dose cohorts for part D will be enrolled in the study. The starting dose in Part A will be 0.5 mg/kg as a single dose. Subsequent doses in Part A and all doses in Parts B, C, and D will be based on the results of previous cohorts and/or previous parts of the study. Part B will start after all subjects in Part A have comple ...read more on ClinicalTrials.org

Drug - Placebo

Matching placebo capsules will be administered once in the morning before breakfast

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A Phase 1-2, Dose-Escalating, 4-Part Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of AT-007 in Healthy Adult Subjects and Adult Subjects With Classic Galactosemia

common.study.values.clinical-trial-id

NCT04117711

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dJ6o2d