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Epinephrine Nasal Spray for Allergy

Not yet recruiting at 1 trial location
SP
Overseen BySenior Principal Scientist, Clinical R&D
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Hikma Pharmaceuticals USA Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NT

Nageshwar Thudi, PhD

Principal Investigator

Hikma Pharmaceuticals USA Inc.

Are You a Good Fit for This Trial?

This trial is for children and teens aged 2 to 17 years who have a diagnosed Type I allergy. Participants must weigh at least 15 kg (about 33 lbs).

Inclusion Criteria

Fertile males must use a condom, have a female partner using highly effective contraception, or practice abstinence from Screening until last visit
Diagnosed with type I allergy with food or venom allergy prone to anaphylactic reactions requiring prescription of epinephrine products
Signed assent form by the child/adolescent
See 6 more

Exclusion Criteria

Clinically significant findings at Screening in vital signs, ECG, physical and nasal cavity examination
I have a higher risk of brain bleeding due to certain conditions or past injuries.
I have been diagnosed with hyperthyroidism, diabetes, liver, or kidney problems.
See 14 more

What Are the Treatments Tested in This Trial?

Interventions

  • Epinephrine Nasal Spray

Trial Overview

The study tests the safety and how the body processes a single dose of epinephrine nasal spray in two weight groups: one group gets a lower dose, and heavier participants get a higher dose. All receive only one treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ≥15 kg to ≤30 kgExperimental Treatment1 Intervention
Group II: >30 kgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hikma Pharmaceuticals USA Inc.

Lead Sponsor

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