EpinephrinePhase 2NCT07891780
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
A Phase 2 study testing Epinephrine Nasal Spray, 2.5 mg and Epinephrine Nasal Spray, 5.25 mg in people with Epinephrine and Hypersensitivity, Immediate, run by Hikma Pharmaceuticals USA Inc. at 2 sites in United States.
Trial summary
This Phase 2, open-label, single-arm study will evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single dose of epinephrine nasal spray (ENS) in children and adolescents 2 to 17 years of age with a diagnosed Type I allergy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Epinephrine, Hypersensitivity, Immediate, Anaphylaxis
- What is being tested?
- Epinephrine Nasal Spray, 2.5 mg and Epinephrine Nasal Spray, 5.25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children and adolescents aged between 2 and 17 years (inclusive) at the time of Screening.
- Diagnosed with type I allergy with food or venom allergy, which is prone to anaphylactic reactions and requires the prescription of epinephrine products.
- Body weight ≥15 kg (33 lbs) measured in light clothing and without shoes.
- Have a BMI within the 5-95% percentile, considering the regional, sex and age-specific growth charts.
- Signed informed consent form (ICF) by the parent/legally authorised representative (LAR).
- Signed assent form by the child/adolescent.
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- Willingness to comply with the requirements and restrictions listed in the ICF and this Clinical Study Protocol.
- Females of childbearing potential must agree to use highly effective methods of contraception from the beginning of Screening until the last visit.
- Note: acceptable highly effective methods of contraception include methods that can achieve a failure rate of less than 1% per year when used consistently and correctly: the intrauterine device; intrauterine system; bilateral tubal occlusion (must be documented); oral, intravaginal, transdermal, injectable, and implantable methods of hormonal contraception associated with inhibition of ovulation (combined estrogen and progesterone containing; or progesterone-only hormonal contraception); vasectomised partner (must be documented); or sexual abstinence (only when it is the usual and preferred lifestyle of the participant).
- Note 1: Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of the contraception method.
- Note 2: Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the surgical success.
- Note 3: In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the study participant
- If the participant is a fertile male, the participant must use a condom, or his female partner of childbearing potential must use a highly effective form of contraception described in the note above, or the participant can practice abstinence (only when it is the usual and preferred lifestyle of the participant) from the beginning of Screening until the last visit.
Who cannot join
- Prior nasal fractures, severe nasal injuries or surgeries, nostril or septum piercings, as well as presence of nasal obstruction, that could interfere with nasal spray administration.
- Known cardiac comorbidity (including hypertension, cardiac arrhythmias, tachycardia [PR >140/min in participants ≤10 years old or >100/min in participants >10 years], coronary artery disease, or any other structural or electrophysiological diagnosis).
- Note: To account for stress-related elevations, if BP and/or PR are elevated on Day 1 pre-dose, the Investigator may consider repeating the measurement prior to participant exclusion. If BP and/or PR are elevated on repeated measurements, the participant should be excluded.
- Known increased risk of cerebrovascular haemorrhage (i.e., arteriovenous malformations, aneurysms, recent head traumas, or history of brain tumours).
- Diagnosis of hyperthyroidism, diabetes, hepatic or renal dysfunction.
- Presence of acute illness, such as common cold, flu or other acute infection, within 7 days prior to Day 1.
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- History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardise the safety of the participant or impact the validity of the study results.
- Clinically significant findings at Screening in vital signs measurements, ECG findings, physical and nasal cavity examination.
- Positive urine screen for alcohol, drugs of abuse and cotinine for participants ≥12 years of age.
- Use of the following substances within 72 hours prior to Day 1: any intranasal or sinus medication (including corticosteroids, decongestants, saline washes).
- Use of the following substances within 14 days prior to Day 1: beta-adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors.
- Use of the following substances within 24 hours prior to Day 1: other catecholamines (e.g., norepinephrine, dopamine) or vasopressors.
- Use of the following substances within 7 days prior to Day 1: ergot alkaloids; levothyroxine (if not on a stable, replacement dose); strong inhibitors or inducers of CYP3A4, CYP2D6, CYP2C9, and CYP1A2 enzymes; catechol-O-methyltransferase (COMT) inhibitors (e.g., entacapone); antiarrhythmics, other alpha-adrenergic blockers, reserpine, and clonidine-type antihypertensives.
- Participant not willing to avoid using methylxanthine-containing products (e.g., chocolate, cocoa, or cola) within 24 hours before dosing on Day 1.
- Known reaction or sensitivity to epinephrine or any of the ingredients of the product, including sodium bisulfite.
- Females who are pregnant or breastfeeding.
- Lifetime use of tobacco, vape or nicotine-containing products.
- Participation in another clinical study with any investigational medicinal product within 90 days before dosing.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
CenExel
Marlton, New Jersey, 08053
CenExel
Salt Lake City, Utah, 84107
About this study
This Phase 2, open-label, single-arm study will evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single dose of epinephrine nasal spray (ENS) in children and adolescents 2 to 17 years of age with a diagnosed Type I allergy.
Approximately 44 participants will be enrolled in two body-weight cohorts.
Read more
- Participants weighing >30 kg will receive a single 5.25 mg dose of ENS, and
- Participants weighing ≥15 kg to ≤30 kg will receive a single 2.5 mg dose of ENS.
The study will assess plasma epinephrine concentrations, changes in blood pressure and pulse rate, and safety and tolerability following administration of ENS. Participants will be monitored for 4 hours after dosing and will complete safety follow-up through approximately Day 15.
- Conditions
- Epinephrine, Hypersensitivity, Immediate, Anaphylaxis
- Being tested
- Epinephrine Nasal Spray, 2.5 mg, Epinephrine Nasal Spray, 5.25 mg
- Medical subject headings
- Hypersensitivity, Immediate, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine Nasal Spray, 2.5 mgDrug
A single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 2.5 mg for participants weighing ≥15 to ≤30 kg.
Epinephrine Nasal Spray, 5.25 mgDrug
A single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 5.25 mg for participants weighing >30 kg.
| Study group | Role | What they receive |
|---|---|---|
| ≥15 kg to ≤30 kg | Experimental | Epinephrine Nasal Spray, 2.5 mg Receives: Drug: Epinephrine Nasal Spray, 2.5 mg |
| >30 kg | Experimental | Epinephrine Nasal Spray, 5.25 mg Receives: Drug: Epinephrine Nasal Spray, 5.25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the PK of a single dose of ENS in children and adolescents (2-17 years)
Epinephrine Maximal concentration (Cmax)
Measured: 0-240 minutes
To assess the PK of a single dose of ENS in children and adolescents (2-17 years)
Time at maximal concentration (Tmax)
Measured: 0-240 minutes
To assess the PK of a single dose of ENS in children and adolescents (2-17 years)
Area under the curve 0-240 min. (AUC0-240) based on observed plasma concentration-time data
Measured: 0-240 minutes
Secondary outcomes (5)
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Maximum effect (Emax) for Systolic blood pressure (SBP) until 240 min. post-dose.
Measured: until 240 minutes post-dose
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Maximum effect (Emax) for Diastolic blood pressure (DBP) until 240 min. post-dose.
Measured: until 240 minutes post-dose
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Maximum effect (Emax) for Pulse rate (PR) until 240 min. post-dose.
Measured: until 240 minutes post-dose
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Maximum effect (Emax) for Mean Arterial Pressure (MAP) until 240 min. post-dose.
Measured: until 240 minutes post-dose
Occurrence of Treatment-emergent Adverse Events (TEAE) [Safety and Tolerability]
Occurrence of Treatment-emergent Adverse Events (TEAE) until Day 15, after a single dose of ENS in children and adolescents (2-17 years)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completion8 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpinephrineStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- \>30 kg: 5.25 mg ENS ≥15 kg to ≤30 kg: 2.5 mg ENS
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nageshwar Thudi, PhD, Study director, Hikma Pharmaceuticals USA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891780
- Sponsor's protocol ID
- HKM-ENS-001
- Other IDs
- 2026-527257-19
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
- ClinicalTrials.gov ID
- NCT07891780
- Acronym / sponsor ID
- HKM-ENS-001
- Conditions
- Epinephrine, Hypersensitivity, Immediate, Anaphylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hikma Pharmaceuticals USA Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 8 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Oct 2026 (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 Phase 2, open-label, single-arm study will evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single dose of epinephrine nasal spray (ENS) in children and adolescents 2 to 17 years of age with a diagnosed Type I allergy.
Approximately 44 participants will be enrolled in two body-weight cohorts.
- Participants weighing >30 kg will receive a single 5.25 mg dose of ENS, and
- Participants weighing ≥15 kg to ≤30 kg will receive a single 2.5 mg dose of ENS.
The study will assess plasma epinephrine concentrations, changes in blood pressure and pulse rate, and safety and tolerability following administration of ENS. Participants will be monitored for 4 hours after dosing and will complete safety follow-up through approximately Day 15.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- >30 kg: 5.25 mg ENS ≥15 kg to ≤30 kg: 2.5 mg ENS
| Arm | Type | Receives |
|---|---|---|
| ≥15 kg to ≤30 kg | Experimental | Drug: Epinephrine Nasal Spray, 2.5 mgEpinephrine Nasal Spray, 2.5 mg |
| >30 kg | Experimental | Drug: Epinephrine Nasal Spray, 5.25 mgEpinephrine Nasal Spray, 5.25 mg |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male and female children and adolescents aged between 2 and 17 years (inclusive) at the time of Screening.
- Diagnosed with type I allergy with food or venom allergy, which is prone to anaphylactic reactions and requires the prescription of epinephrine products.
- Body weight ≥15 kg (33 lbs) measured in light clothing and without shoes.
- Have a BMI within the 5-95% percentile, considering the regional, sex and age-specific growth charts.
- Signed informed consent form (ICF) by the parent/legally authorised representative (LAR).
Key exclusion criteria (18 listed)
- Prior nasal fractures, severe nasal injuries or surgeries, nostril or septum piercings, as well as presence of nasal obstruction, that could interfere with nasal spray administration.
- Known cardiac comorbidity (including hypertension, cardiac arrhythmias, tachycardia [PR >140/min in participants ≤10 years old or >100/min in participants >10 years], coronary artery disease, or any other structural or electrophysiological diagnosis).
- Note: To account for stress-related elevations, if BP and/or PR are elevated on Day 1 pre-dose, the Investigator may consider repeating the measurement prior to participant exclusion. If BP and/or PR are elevated on repeated measurements, the participant should be excluded.
- Known increased risk of cerebrovascular haemorrhage (i.e., arteriovenous malformations, aneurysms, recent head traumas, or history of brain tumours).
- Diagnosis of hyperthyroidism, diabetes, hepatic or renal dysfunction.
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 |
|---|---|---|
| Epinephrine Nasal Spray, 2.5 mgA single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 2.5 mg for participants weighing ≥15 to ≤30 kg. | Drug | ≥15 kg to ≤30 kg |
| Epinephrine Nasal Spray, 5.25 mgA single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 5.25 mg for participants weighing >30 kg. | Drug | >30 kg |
Primary outcome
To assess the PK of a single dose of ENS in children and adolescents (2-17 years)
Time frame: 0-240 minutes
Epinephrine Maximal concentration (Cmax)
To assess the PK of a single dose of ENS in children and adolescents (2-17 years)
Time frame: 0-240 minutes
Time at maximal concentration (Tmax)
To assess the PK of a single dose of ENS in children and adolescents (2-17 years)
Time frame: 0-240 minutes
Area under the curve 0-240 min. (AUC0-240) based on observed plasma concentration-time data
5 secondary outcomes
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Time frame: until 240 minutes post-dose
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Time frame: until 240 minutes post-dose
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Time frame: until 240 minutes post-dose
To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)
Time frame: until 240 minutes post-dose
Occurrence of Treatment-emergent Adverse Events (TEAE) [Safety and Tolerability]
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Nageshwar Thudi, PhD study director
Hikma Pharmaceuticals USA Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epinephrine Nasal Spray, 2.5 mg and Epinephrine Nasal Spray, 5.25 mg in people with Epinephrine and Hypersensitivity, Immediate, run by Hikma Pharmaceuticals USA Inc. 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 13 inclusion and 18 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: opening soon, as of the sponsor's last update on 23 Oct 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Principal Scientist, Clinical R&D ((614) 276-4000, usclinicalgeneralemail@hikma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the PK of a single dose of ENS in children and adolescents (2-17 years) (time frame: 0-240 minutes). The study lists 3 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 23 Oct 2026.