NCT05351086

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Pulmatrix Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PUR3100	PUR3100 is an inhalation powder containing DHE, an anti-migraine treatment with broad spectrum agonist activity against 5-hydroxytryptamine (5-HT), dopamine, and adrenergic receptors. PUR3100 is provided as 500 µg dose strength capsules. Each capsule contains the drug substance, DHE mesylate, with mannitol, leucine, and sodium chloride as excipients.
DRUG	Dihydroergotamine (D.H.E 45)	D.H.E. 45 is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. It is supplied as a clear, colorless solution supplied in sterile ampules for IV, intramuscular, or subcutaneous administration containing (per mL) DHE mesylate, USP 1 mg, ethanol, 94% w/w. 6.2% by volume, glycerin 15% by weight, and water for injection.
OTHER	Matching Placebo for PUR3100	Each capsule of matching placebo is filled with iSPERSE powder comprised of mannitol, leucine, and sodium chloride. The PUR3100 inhalation powder is administered using the supplied RS01 inhalation device (RS01 UHR2, Plastiape S.p.A.).
OTHER	Matching Placebo for D.H.E 45	The matching placebo for D.H.E. 45 is 0.9% sterile saline for injection.

Timeline

• Start date: 2022-06-09
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2022-04-28
• Last updated: 2022-12-23

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study