Cyanide PoisoningPhase 1NCT05194358
Study of SIAN Nasal Spray in Healthy Adults
A Phase 1 study testing Stabilized Isoamyl Nitrite (SIAN) in people with Cyanide Poisoning, run by Emergent BioSolutions at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cyanide Poisoning
- What is being tested?
- Stabilized Isoamyl Nitrite (SIAN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2021to 13 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- Not of childbearing potential: surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and screening follicle-stimulating hormone [FSH] > 30 mIU/mL)
- Women of childbearing potential who are not planning to be pregnant during the study period and who meet criteria i - iv: i. Negative serum pregnancy test at Screening Visit ii. Negative urine pregnancy test prior to dosing at Day -1 (Baseline) iii. Not currently breastfeeding iv. Using one of the following highly effective methods of contraception during the study period:
- Combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g. implants, pills, patches) initiated ≥30 days prior to Day 1
- Intrauterine device (IUD) inserted ≥30 days prior to Day 1
- Double barrier type of birth control (e.g. female condom, diaphragm or cervical cap and spermicidal foam/gel/cream/suppository, or male condom with diaphragm, male condom with cervical cap)
- Body mass index (BMI) between 18 and 34 kg/m2, inclusive.
Who cannot join
- 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.
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- 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
- Localized skin cancer that has been resected at least 4 weeks prior to Screening (including squamous cell and basal cell carcinomas).
- History of intolerance to nitrites, nitrates or IAN and/or any of the study drug components (including ELSO (Epoxidized linseed oil)).
- Contraindication to methylene blue as per the medical history of the subject.
- History of nasal disorders, chronic sinusitis, sinonasal surgery including rhinoplasty, or significant abnormalities of the nasal anatomy including septum deviations.
- Piercing of the nose that could interfere with study drug administration or absorption or study assessments, as judged by the investigator.
- Participation in another clinical study and/or use of any drug, vaccine, device or combination product in the context of a clinical research study within 30 days prior to Baseline (Day -1) or administration of a biological product in the context of a clinical research study within 90 days prior to Baseline (Day -1).
- Red blood cell G6PD (glucose-6-phosphate dehydrogenase) deficiency, by laboratory testing at Screening.
- Any lab values outside the normal range that are deemed to be clinically significant in the PI and/or Medical Monitor's judgement.
- Hemoglobin (Hb) < 12.0 g/dL for females or < 13.5 g/dL for males at Screening.
- Methemoglobin > 3% at Screening or Day -1.
- Any history or family history of congenital methemoglobinemia.
- Has a positive serology test for human immunodeficiency virus antibodies, hepatitis B virus surface antigen or hepatitis C virus antibodies at Screening.
- Any ECG assessment that is outside the normal range that is deemed clinically significant per the Principal Investigator's and/or Medical Monitor's judgement at Screening or Day -1 ECG; however, abnormal readings for the following benign conditions will be acceptable for inclusion in the study: early repolarization, nonspecific ST-T wave pattern or changes, right axis deviation (axis ≤ 110°), first degree atrioventricular block (PR interval < 240 millisecond (ms)), nonspecific intraventricular conduction delay (QRS < 120 ms), indeterminate axis and short PR interval (no delta wave present). On standard 12-lead ECG, a QTcF interval of >450 ms for males and >470 for females. If a single ECG QTcF is >450 ms for males and >470 for females, two more ECGs will be obtained over a 5-10 min period and the average of the QTcF interval from the 3 ECGs readings will be used to determine eligibility.
- Any scheduled or anticipated medical intervention or surgical procedure, including dental procedures, during study participation, from Screening through Day 8.
- History of chronic or current tobacco use. Subjects with more than 10 years of tobacco cessation might be included if they are considered healthy according to Investigator's opinion and medical history.
- History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or positive alcohol breath test at Screening or Day -1.
- Positive test result on urine drug screen (cocaine, marijuana, phencyclidine, amphetamine, methamphetamine, opioids including methadone, ecstasy), any evidence of ongoing drug abuse or dependence (including alcohol), or recent history (over the past five years) of treatment for alcohol or drug abuse within 1 year prior to screening or positive standard urine drug test at Screening or Day -1.
- History of the use of poppers, (alkyl nitrites) or positive standard urine drug screen.
- Has donated plasma or blood or intends to donate within 30 days prior to Day 1 or during the course of the study.
- Has received any medication, either prescription or non-prescription, including dietary supplements or herbal medications (e.g., quercetin, Gingko Biloba, palmetto, etc.), within 14 days or less than 5 half-lives prior to Baseline (Day -1) and is unable to refrain from any medication during study participation. If more than 5-half-lives is passed from the last dose of the over-the-counter medications listed in the protocol prior to admission Day-1, subjects will be eligible. The only allowed exception is hormonal birth control.
- Psychological and/or emotional problems, which would render the informed consent invalid or limit the ability of the subject to comply with the study requirements.
- Member or immediate family member of an investigative site or Sponsor team member.
- Known lack of treatment compliance from prior studies or ongoing medical care based on medical records and Investigator's assessment.
- Judged by the Investigator or Sponsor to be inappropriate/ineligible for the study for any other reason.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Austin Clinical Research Unit - PPD Phase I Clinic
Austin, Texas, 78744
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
About this study
Official title: Phase 1, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Stabilized Isoamyl Nitrite (SIAN) Nasal Spray in Healthy Adults
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.
Read the detailed description
This is a Phase 1, open label, single ascending dose (SAD) study of Stabilized Isoamyl Nitrite (SIAN) nasal spray to assess safety, PK and PD.
The study will consist of seven cohorts, with up to 10 subjects planned per cohort, for a total of 70 subjects. Each cohort will include 10 healthy male or non-pregnant female subjects, aged 18 to 45 years inclusive. There will be a screening period from Day -28 to Day -2 for all study subjects. Subjects will stay overnight at the site the day prior to dosing (Day -1) and the day of dosing (Day 1). They will be evaluated until 24 hours after dosing (Day 2) prior to discharge from the phase 1 clinic. Subjects will return for an End of Study Visit at Day 8 after dosing.
Within cohorts one and two, the first two subjects will be dosed as sentinels, while cohorts three to seven will dose the first three subjects as sentinels. Upon completion of the Day 8 (end of study/early withdrawal) visit, safety data, including clinical and laboratory data, and raw PD/PK data will be reviewed by the Principal Investigator (PI) and Medical Monitor (MM) and Safety Monitoring Committee (SMC). If exposure is evident based on raw IAA PK data and PD response signals are detected, the remaining subjects (eight subjects for cohorts one and two and seven subjects for cohorts three to seven) will be dosed. If no exposure and/or PD response signals are detected during sentinel dosing, escalation to the next cohort may be permitted by the SMC.
For cohorts where all 10 subjects are dosed, the SMC will review the entire cohort data through each subject's Day 8 visit and provide a recommendation on either, (a) dose escalation to the next cohort, (b) lowering the next dose level, or (c) stopping enrollment based on dose-limiting toxicity.
Each new cohort will be dosed following the same procedure as the prior cohort.
- Conditions
- Cyanide Poisoning
- Being tested
- Stabilized Isoamyl Nitrite (SIAN)
- Keywords
- Cyanide Exposure, Cyanide, Stabilized Isoamyl Nitrite (SIAN), Isoamyl Nitrite (IAN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilized Isoamyl Nitrite (SIAN)Drug
SIAN is comprised of isoamyl nitrite (IAN) stabilized with 4% by weight epoxidized linseed oil (ELSO) and administered by intranasal (IN) delivery as a nasal spray.
A syringe-based spray device will be used to administer the SIAN product. This syringe-based spray device, consists of a Hamilton type syringe connected to a tip that functions as an atomizer, to provide an optimal spray plume for nasal absorption while minimizing exposure to lungs.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 SIAN | Experimental | SIAN dose of 0.28 mg/kg (20 μL) will be administered from a single syringe-based spray device into left nostril. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
| Cohort 2 SIAN | Experimental | SIAN dose of 0.73 mg/kg (50 μL) will be administered from a single syringe-based spray device into left nostril. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
| Cohort 3 SIAN | Experimental | SIAN dose of 1.45 mg/kg (100 μL) will be administered from a single syringe-based spray device into left nostril. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
| Cohort 4 SIAN | Experimental | SIAN dose of 2.18 mg/kg (150 μL) will be administered from a single syringe-based spray device into left nostril. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
| Cohort 5 SIAN | Experimental | 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. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
| Cohort 6 SIAN | Experimental | 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. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
| Cohort 7 SIAN | Experimental | 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. Receives: Drug: Stabilized Isoamyl Nitrite (SIAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Related Serious Adverse Events (SAEs)
Incidence of related SAEs
Measured: Through Day 8
Methemoglobin (MetHb) level
To determine the dose that will result in a 6-10% MetHb level
Measured: Through 360 minutes post-dose
Secondary outcomes (26)
PK Endpoint: Maximum observed concentration (Cmax) of Isoamyl Alcohol (IAA metabolite)
Assess the maximum observed concentration (Cmax) of IAA
Measured: Through 59 minutes post-dose
PK Endpoint: Time at which Cmax occurs (Tmax) of IAA
Assess the time at which Cmax occurs (Tmax) of IAA
Measured: Through 59 minutes post-dose
PK Endpoint: Apparent first order terminal elimination half-life (t 1/2) of IAA
Assess the apparent first order terminal elimination half-life (t 1/2) of IAA
Measured: Through 59 minutes post-dose
PK Endpoint: Area under the concentration-time curve from time 0 to 10 minutes post-dose (AUC 0-10min) of IAA
Assess the area under the concentration-time curve from time 0 to 10 minutes post-dose (AUC 0-10min) of IAA
Measured: Through 59 minutes post-dose
PK Endpoint: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) of IAA
Assess the area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) of IAA
Measured: Through 59 minutes post-dose
PK Endpoint: AUC 0-t plus the additional area extrapolated to infinity (AUC 0-inf) of IAA
Assess the AUC 0-t plus the additional area extrapolated to infinity (AUC 0-inf) of IAA
Measured: Through 59 minutes post-dose
PD Endpoint: Cmax of MetHb
Assess the Cmax of MetHb
Measured: Through 360 minutes post-dose
PD Endpoint: AUC0-t of MetHb
Assess the AUC0-t of MetHb
Measured: Through 360 minutes post-dose
PD Endpoint: t1/2 of MetHb
Assess the t1/2 of MetHb
Measured: Through 360 minutes post-dose
PD Endpoint: The maximum change from baseline (Emax) of MetHb
Assess the maximum change from baseline (Emax) of MetHb
Measured: Through 360 minutes post-dose
PD Endpoint: Time of reaching Emax (TEmax) of MetHb
Assess Time of reaching Emax (TEmax) of MetHb
Measured: Through 360 minutes post-dose
PD Endpoint: Time to recovery to baseline values of MetHb
Assess the time to recovery to baseline values of MetHb
Measured: Through 360 minutes post-dose
PD Endpoint: Area under the effect curve (AUEC(0-t)) of the fraction of MetHb (%)
Assess the area under the effect curve (AUEC(0-t)) of the fraction of MetHb (%)
Measured: Through 360 minutes post-dose
PD Endpoint: for BP maximum change from baseline (Emax)
Assess the Emax for BP
Measured: Through 8 hours post dose
PD Endpoint: for BP maximum change from TEmax
Assess the TEmax for BP
Measured: Through 8 hours post dose
PD Endpoint: Time to recovery to baseline values for BP (mm Hg)
Assess the time to recovery to baseline values for BP (mm Hg)
Measured: Through 8 hours post dose
PD Endpoint: Emax for SpO2 by pulse oximetry
Assess the Emax for SpO2
Measured: Through 8 hours post dose
PD Endpoint: TEmax for SpO2 by pulse oximetry
Assess the TEmax for SpO2
Measured: Through 8 hours post dose
PD Endpoint: Time to recovery to baseline SpO2 (%)
Assess the time to recovery to baseline SpO2 (%)
Measured: Through 8 hours post dose
PD Endpoint: Emax for HR (heart rate) (beats/min)
Assess the Emax for HR (beats/min)
Measured: Through 8 hours post dose
PD Endpoint: TEmax for HR (beats/min)
Assess the TEmax for HR (beats/min)
Measured: Through 8 hours post dose
PD Endpoint: Time to recovery to baseline for HR (beats/min)
Assess the time to recovery to baseline for HR (beats/min)
Measured: Through 8 hours post dose
Safety Endpoint: Adverse Events (AEs)
Incidence of AEs
Measured: Through Day 8
Safety Endpoint: Toxicity grade 1 or higher of vital signs
Incidence of toxicity grade 1 or higher of vital signs
Measured: Through Day 8
Safety Endpoint: Toxicity grade 1 or higher of clinical laboratories
Incidence of toxicity grade 1 or higher of clinical laboratories
Measured: Through Day 8
Safety Endpoint: Orthostatic Hypotension
Incidence of orthostatic hypotension (drop in systolic blood pressure of at least 20 millimeters of mercury (mm Hg) or diastolic blood pressure of at least 10 mm Hg within three minutes of standing).
Measured: Through 60 minutes Post-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start21 Dec 2021
- Primary completion29 Sep 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyanide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194358
- Sponsor's protocol ID
- EBS-SIN-001
- Status last verified
- May 2025
- First submitted
- 4 Jan 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Stabilized Isoamyl Nitrite (SIAN) Nasal Spray in Healthy Adults
- ClinicalTrials.gov ID
- NCT05194358
- Acronym / sponsor ID
- EBS-SIN-001
- Conditions
- Cyanide Poisoning
- Keywords
- Cyanide Exposure, Cyanide, Stabilized Isoamyl Nitrite (SIAN), Isoamyl Nitrite (IAN)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, open label, single ascending dose (SAD) study of Stabilized Isoamyl Nitrite (SIAN) nasal spray to assess safety, PK and PD.
The study will consist of seven cohorts, with up to 10 subjects planned per cohort, for a total of 70 subjects. Each cohort will include 10 healthy male or non-pregnant female subjects, aged 18 to 45 years inclusive. There will be a screening period from Day -28 to Day -2 for all study subjects. Subjects will stay overnight at the site the day prior to dosing (Day -1) and the day of dosing (Day 1). They will be evaluated until 24 hours after dosing (Day 2) prior to discharge from the phase 1 clinic. Subjects will return for an End of Study Visit at Day 8 after dosing.
Within cohorts one and two, the first two subjects will be dosed as sentinels, while cohorts three to seven will dose the first three subjects as sentinels. Upon completion of the Day 8 (end of study/early withdrawal) visit, safety data, including clinical and laboratory data, and raw PD/PK data will be reviewed by the Principal Investigator (PI) and Medical Monitor (MM) and Safety Monitoring Committee (SMC). If exposure is evident based on raw IAA PK data and PD response signals are detected, the remaining subjects (eight subjects for cohorts one and two and seven subjects for cohorts three to seven) will be dosed. If no exposure and/or PD response signals are detected during sentinel dosing, escalation to the next cohort may be permitted by the SMC.
For cohorts where all 10 subjects are dosed, the SMC will review the entire cohort data through each subject's Day 8 visit and provide a recommendation on either, (a) dose escalation to the next cohort, (b) lowering the next dose level, or (c) stopping enrollment based on dose-limiting toxicity.
Each new cohort will be dosed following the same procedure as the prior cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)SIAN dose of 0.28 mg/kg (20 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 2 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)SIAN dose of 0.73 mg/kg (50 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 3 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)SIAN dose of 1.45 mg/kg (100 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 4 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)SIAN dose of 2.18 mg/kg (150 μL) will be administered from a single syringe-based spray device into left nostril. |
| Cohort 5 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)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. |
| Cohort 6 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)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. |
| Cohort 7 SIAN | Experimental | Drug: Stabilized Isoamyl Nitrite (SIAN)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilized Isoamyl Nitrite (SIAN)SIAN is comprised of isoamyl nitrite (IAN) stabilized with 4% by weight epoxidized linseed oil (ELSO) and administered by intranasal (IN) delivery as a nasal spray. A syringe-based spray device will be used to administer the SIAN product. This syringe-based spray device, consists of a Hamilton type syringe connected to a tip that functions as an atomizer, to provide an optimal spray plume for nasal absorption while minimizing exposure to lungs. | Drug | Cohort 1 SIAN, Cohort 2 SIAN, Cohort 3 SIAN, Cohort 4 SIAN, Cohort 5 SIAN, Cohort 6 SIAN, Cohort 7 SIAN |
Primary outcome
Related Serious Adverse Events (SAEs)
Time frame: Through Day 8
Incidence of related SAEs
Methemoglobin (MetHb) level
Time frame: Through 360 minutes post-dose
To determine the dose that will result in a 6-10% MetHb level
26 secondary outcomes
PK Endpoint: Maximum observed concentration (Cmax) of Isoamyl Alcohol (IAA metabolite)
Time frame: Through 59 minutes post-dose
PK Endpoint: Time at which Cmax occurs (Tmax) of IAA
Time frame: Through 59 minutes post-dose
PK Endpoint: Apparent first order terminal elimination half-life (t 1/2) of IAA
Time frame: Through 59 minutes post-dose
PK Endpoint: Area under the concentration-time curve from time 0 to 10 minutes post-dose (AUC 0-10min) of IAA
Time frame: Through 59 minutes post-dose
PK Endpoint: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) of IAA
Time frame: Through 59 minutes post-dose
PK Endpoint: AUC 0-t plus the additional area extrapolated to infinity (AUC 0-inf) of IAA
Time frame: Through 59 minutes post-dose
PD Endpoint: Cmax of MetHb
Time frame: Through 360 minutes post-dose
PD Endpoint: AUC0-t of MetHb
Time frame: Through 360 minutes post-dose
PD Endpoint: t1/2 of MetHb
Time frame: Through 360 minutes post-dose
PD Endpoint: The maximum change from baseline (Emax) of MetHb
Time frame: Through 360 minutes post-dose
PD Endpoint: Time of reaching Emax (TEmax) of MetHb
Time frame: Through 360 minutes post-dose
PD Endpoint: Time to recovery to baseline values of MetHb
Time frame: Through 360 minutes post-dose
PD Endpoint: Area under the effect curve (AUEC(0-t)) of the fraction of MetHb (%)
Time frame: Through 360 minutes post-dose
PD Endpoint: for BP maximum change from baseline (Emax)
Time frame: Through 8 hours post dose
PD Endpoint: for BP maximum change from TEmax
Time frame: Through 8 hours post dose
PD Endpoint: Time to recovery to baseline values for BP (mm Hg)
Time frame: Through 8 hours post dose
PD Endpoint: Emax for SpO2 by pulse oximetry
Time frame: Through 8 hours post dose
PD Endpoint: TEmax for SpO2 by pulse oximetry
Time frame: Through 8 hours post dose
PD Endpoint: Time to recovery to baseline SpO2 (%)
Time frame: Through 8 hours post dose
PD Endpoint: Emax for HR (heart rate) (beats/min)
Time frame: Through 8 hours post dose
PD Endpoint: TEmax for HR (beats/min)
Time frame: Through 8 hours post dose
PD Endpoint: Time to recovery to baseline for HR (beats/min)
Time frame: Through 8 hours post dose
Safety Endpoint: Adverse Events (AEs)
Time frame: Through Day 8
Safety Endpoint: Toxicity grade 1 or higher of vital signs
Time frame: Through Day 8
Safety Endpoint: Toxicity grade 1 or higher of clinical laboratories
Time frame: Through Day 8
Safety Endpoint: Orthostatic Hypotension
Time frame: Through 60 minutes Post-Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stabilized Isoamyl Nitrite (SIAN) in people with Cyanide Poisoning, run by Emergent BioSolutions at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Related Serious Adverse Events (SAEs) (time frame: Through Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.