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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults

Healthy Clinical Trial

Official title:
A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults

Clinical Trial Summary

A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Healthy Adults

Clinical Trial Description

This is a randomized, parallel group, double-blind, double dummy study. Following screening and confirmation of eligibility, twenty-four healthy subjects will be evenly randomized to 1 of the 4 dose groups of 6 subjects each. Subjects will receive intravenous (IV) dihydroergotamine (D.H.E) or IV placebo and dry powder inhalation of 0.5mg of PUR3100, 1.0 mg of PUR 3100, 1.5 mg of PUR 3100, or placebo. All potential subjects will complete screening between 28 days and 2 days prior to study unit check-in on Day -1. Subjects will remain in the study unit for 3 days post check-in and will be dosed each day at the study site. A follow up visit will occur 4 days after the last dose of study drug, on Day 7 of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05351086
Study type Interventional
Source Pulmatrix Inc.
Contact
Status Completed
Phase Phase 1
Start date June 9, 2022
Completion date September 22, 2022
View Details
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