Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PUR3100 · 1 trial · 1 indication
To determine the safety and tolerability of single doses of inhaled PUR3100 in healthy through the review of AEs
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the maximum drug concentration in blood plasma. This will also be compared to Cmax of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the last observed quantifiable concentration of PUR 3100 in blood plasma. This will also be compared to Clast of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time time it takes for a drug to reach the maximum concentration (Cmax). This will also be compared to Tmax of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time time it takes for a drug to reach the last measurable concentration of PUR 3100 in blood plasma. This will also be compared to Tlast of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the drug concentration in blood plasma over time. This will also be compared to the AUC (0-t), AUC (0-inf), and AUC (0-2h) of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time it takes for the amount of drug in the blood to reduce by 50%. This will also be compared to the half life of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects. This will also be compared to the CL/F of participants who receive IV D.H.E. 45.
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects. This will also be compared to the Vz/F of participants who receive IV D.H.E. 45.
| Arm | Type | Description |
|---|---|---|
| Inhaled placebo and IV D.H.E. 45 1 mg | EXPERIMENTAL | - |
| Inhaled PUR3100 0.5 mg and IV placebo | EXPERIMENTAL | - |
| Inhaled PUR3100 1.0 mg and IV placebo | EXPERIMENTAL | - |
| Inhaled PUR3100 1.5 mg and IV placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PUR3100 | DRUG | 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. |
| Dihydroergotamine (D.H.E 45) | DRUG | 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. |
| Matching Placebo for PUR3100 | OTHER | 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.). |
| Matching Placebo for D.H.E 45 | OTHER | The matching placebo for D.H.E. 45 is 0.9% sterile saline for injection. |
Inclusion Criteria: 1. Male or female subjects aged 18 to 55 years of age with a body mass index ≥17 and ≤35 kg/m2. 2. Subject has normal screening and baseline blood pressure, defined as a systolic value ≥90 mmHg and ≤140 mmHg and a diastolic value \>60 mmHg and \<90 mmHg. 3. Female subjects who a...
PUR3100 is an investigational small molecule developed by Pulmatrix, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific therapeutic indication for PUR3100 has not been publicly disclosed.
PUR3100 is being developed by Pulmatrix, Inc., a biopharmaceutical company that trades under the ticker symbol PULM. Pulmatrix is the sponsor of the clinical program evaluating PUR3100.
PUR3100 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.
PUR3100 has been evaluated in one completed Phase 1 trial, NCT05351086, titled A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Healthy Adults. The trial enrolled 26 participants in Australia and was randomized, double-blind, and controlled.
The Phase 1 trial NCT05351086 was a randomized, double-blind, controlled study of PUR3100 in healthy adult volunteers. It enrolled 26 participants of all sexes, aged 18 years and older, at sites in Australia, and assessed safety, tolerability, and pharmacokinetics. The trial is now completed.