Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients

NCT07891780 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: HKM-ENS-0012026-527257-19
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Epinephrine; Hypersensitivity, Immediate; Anaphylaxis

Outcome Measures

Primary Outcomes (3)

• To assess the PK of a single dose of ENS in children and adolescents (2-17 years)

  Epinephrine Maximal concentration (Cmax)

  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)

  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

  0-240 minutes

Secondary Outcomes (5)

• To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)

  until 240 minutes post-dose

• To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)

  until 240 minutes post-dose

• To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)

  until 240 minutes post-dose

• To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years)

  until 240 minutes post-dose

• Occurrence of Treatment-emergent Adverse Events (TEAE) [Safety and Tolerability]

  15 days

Study Arms (2)

≥15 kg to ≤30 kg

EXPERIMENTAL

Epinephrine Nasal Spray, 2.5 mg

Drug: Epinephrine Nasal Spray, 2.5 mg

>30 kg

EXPERIMENTAL

Epinephrine Nasal Spray, 5.25 mg

Drug: Epinephrine Nasal Spray, 5.25 mg

Interventions

Epinephrine Nasal Spray, 2.5 mg DRUG

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.

≥15 kg to ≤30 kg

Epinephrine Nasal Spray, 5.25 mg DRUG

A single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 5.25 mg for participants weighing \>30 kg.

>30 kg

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Hikma Pharmaceuticals USA Inc.: lead

Study Sites (2)

CenExel

Marlton, New Jersey, 08053, United States

Location

CenExel

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases

Study Officials

• Nageshwar Thudi, PhD

  Hikma Pharmaceuticals USA Inc.

  STUDY DIRECTOR

Central Study Contacts

Senior Principal Scientist, Clinical R&D

CONTACT

(614) 276-4000; usclinicalgeneralemail@hikma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: \>30 kg: 5.25 mg ENS ≥15 kg to ≤30 kg: 2.5 mg ENS

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: October 23, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): May 8, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)