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drugset / Trial / NCT05045833

Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020

NCT05045833 ↗

Phase 1 Completed 40 enrolled Theriva Biologics, Inc. Spaulding Clinical Research LLC · collab
RandomizedSequentialTriple-blindOther

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-ascending-dose study to assess the PK, safety, and tolerability of SYN-020 oral delayed release capsules (SYN 020) in healthy adults. At least 1 exploratory PD endpoint will also be assessed.

Timeline

Start
2021-10-18
Primary completion
2022-02-22
Completion
2022-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject SYN-020 Protein / enzyme biologic 5 mg Oral
Subject SYN-020 Protein / enzyme biologic 15 mg Oral
Subject SYN-020 Protein / enzyme biologic 45 mg Oral
Subject SYN-020 Protein / enzyme biologic 75 mg Oral

Indications

enteritis