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

NCT05351086 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-12-23

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Pulmatrix Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2022-09-22
Completion
2022-09-22
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351086 on ClinicalTrials.gov