CompletedPhase 1

Study of SIAN Nasal Spray in Healthy Adults

United States47 participantsStarted 2021-12-21

Plain-language summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of Stabilized Isoamyl Nitrite (SIAN) nasal spray in healthy subjects.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Able and willing to provide informed consent (and assent as applicable) voluntarily signed by subject/guardian/legally acceptable representative.
✓. Generally healthy, in the opinion of the PI, medical history, physical examination, vital signs, ECG and laboratory assessments at Screening.
✓. Male or non-pregnant female.
✓. Aged 18-45 years, inclusive, at the time of informed consent.
✓. Have adequate venous access for phlebotomies.
✓. For Women who are EITHER A or B:
✓. Body mass index (BMI) between 18 and 34 kg/m2, inclusive.

Exclusion criteria

✕. Acute disease not resolved at least 4 weeks before Baseline (Day -1).
✕. Any chronic clinical condition that requires active treatment of any kind. However, subjects that are on thyroid hormone replacement therapy are eligible if clinically euthyroid and on a stable dose of thyroxine for at least 2 years.
✕. Medical history of cardiovascular (including symptomatic or asymptomatic aortic or mitral valvular disease, hypertension), renal, pulmonary and neurological conditions.
✕. Active treatment for erectile dysfunction, continuous or on demand, within 4 weeks of baseline.
✕. Orthostatic hypotension (at any time prior to dosing) or history of syncope of any cause.
✕. Clinically significant ocular condition, other than a requirement for corrective lenses.
✕. Any cancer other than the following:
✕. Any non-metastatic cancer (excluding hematologic malignancies) or melanoma of which the subject has been disease-free for at least five years; or

What they're measuring

Related Serious Adverse Events (SAEs)

Timeframe: Through Day 8

Methemoglobin (MetHb) level

Timeframe: Through 360 minutes post-dose

Trial details

NCT IDNCT05194358

SponsorEmergent BioSolutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-29

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