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Entrada Therapeutics Says FDA Declines To Lift Clinical Hold On ENTR-601-44 IND Application

RTTNews | 644 hari yang lalu

Entrada Therapeutics Says FDA Declines To Lift Clinical Hold On ENTR-601-44 IND Application

(RTTNews) - Biopharmaceutical company Entrada Therapeutics, Inc. (TRDA) announced Wednesday the completion of dosing for the first and second cohorts of its Phase 1 clinical trial, ENTR-601-44-101.

Entrada plans to announce data from ENTR-601-44-101 in the second half of 2024.

The primary objective of Entrada's double-blind, single ascending dose Phase 1 clinical trial, which is expected to enroll approximately 40 participants, is to evaluate the safety and tolerability of a single dose of ENTR-601-44 in healthy male volunteers.

ENTR-601-44-101 will also evaluate pharmacokinetics and target engagement, as measured by exon skipping in the skeletal muscle.

Entrada was previously notified by the FDA that the IND for the Phase 1 clinical trial of ENTR-601-44 had been placed on clinical hold.

Despite providing additional information to the FDA, the Company was informed that the Agency declined to lift the clinical hold.

Teg: TRDA

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