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Vasodilator

Study of SIAN Nasal Spray in Healthy Adults

Phase 1

Waitlist Available

Research Sponsored by Emergent BioSolutions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 360 minutes post-dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a nasal spray with stabilized isoamyl nitrite in healthy adults aged 18-45. The spray is absorbed through the nose and enters the bloodstream, where its effects are measured to ensure safety and understand its behavior.

Eligible Conditions

Cyanide Poisoning

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 360 minutes post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 360 minutes post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 360 minutes post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Methemoglobin (MetHb) level

Related Serious Adverse Events (SAEs)

Secondary study objectives

PD Endpoint: AUC0-t of MetHb

PD Endpoint: Area under the effect curve (AUEC(0-t)) of the fraction of MetHb (%)

PD Endpoint: Cmax of MetHb

+23 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Cohort 7 SIANExperimental Treatment1 Intervention

SIAN dose of 4.35 mg/kg (300 μL) will be administered in two syringe-based spray devices, each containing 150 μL, with dose administered in left then right nostril, one device per nostril.

Group II: Cohort 6 SIANExperimental Treatment1 Intervention

SIAN dose of 3.63 mg/kg (250 μL) will be administered in two syringe-based spray devices, each containing 125 μL, with dose administered in left then right nostril, one device per nostril.

Group III: Cohort 5 SIANExperimental Treatment1 Intervention

SIAN dose of 2.90 mg/kg (200 μL) will be administered in two syringe-based spray devices, each containing 100 μL, with dose administered in left then right nostril, one device per nostril. For doses of 2.90 milligram/kilogram (200 microliter) and higher, the dose will be split equally between the two nostrils to avoid drug overflow from the nose (using two syringe-based spray devices one immediately followed by the other). Lower doses will be administered by a single device to one nostril.

Group IV: Cohort 4 SIANExperimental Treatment1 Intervention

SIAN dose of 2.18 mg/kg (150 μL) will be administered from a single syringe-based spray device into left nostril.

Group V: Cohort 3 SIANExperimental Treatment1 Intervention

SIAN dose of 1.45 mg/kg (100 μL) will be administered from a single syringe-based spray device into left nostril.

Group VI: Cohort 2 SIANExperimental Treatment1 Intervention

SIAN dose of 0.73 mg/kg (50 μL) will be administered from a single syringe-based spray device into left nostril.

Group VII: Cohort 1 SIANExperimental Treatment1 Intervention

SIAN dose of 0.28 mg/kg (20 μL) will be administered from a single syringe-based spray device into left nostril.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug