A Study of Nasal Glucagon in Participants With a Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Nasal Glucagon; Oxymetazoline
Intervention description: Administered intranasally.; Administered intranasally.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Glucagon
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in
      participants with a common cold, some of whom will also take a nasal decongestant. The study
      will investigate how the body processes NG and the effect of NG on the body. The study will
      last up to 30 days for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participant presenting a score of 2 or 3 on nasal congestion and/or
             nasal discharge associated with at least one other symptom of common cold, as
             determined by the 8-item Jackson cold scale at screening and prior to dosing of period
             1.

          -  Participant with a body mass index (BMI) greater than or equal to 18.50 and below
             30.00 kilogram per square meter (kg/m²).

          -  Light-, non- or ex-smokers.

          -  Have no clinically significant diseases captured in the medical history or evidence of
             clinically significant findings on physical examination and/or clinical laboratory
             evaluations (hematology, biochemistry, electrocardiogram [ECG] and urinalysis).

        Exclusion Criteria:

          -  Presence of any nose piercings.

          -  History of significant hypersensitivity to glucagon, oxymetazoline or any related
             products (including excipients of the formulations) as well as severe hypersensitivity
             reactions (like angioedema) to any drugs.

          -  Presence of significant gastrointestinal, liver or kidney disease, or any other
             conditions known to interfere with the absorption, distribution, metabolism or
             excretion of drugs or known to potentiate or predispose to undesired effects.

          -  Presence of significant cardiovascular, pulmonary, hematologic, neurological,
             psychiatric, endocrine, immunologic or dermatologic disease.

          -  Presence of severe fever (more than 39.5 degrees Celsius) at screening or prior to
             dosing of period 1.

          -  Presence of clinically significant findings on nasal examination or bilateral anterior
             rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation,
             nasal tumors.

          -  Presence or history of Type 1 or Type 2 diabetes.

          -  Presence or history of significant hypoglycemia or hyperglycemia.

          -  Use of beta-blockers, indomethacin, warfarin or anticholinergic drugs in the previous
             28 days before day 1 of the study.

          -  Fasting blood glucose above 6.1 mmol/L at screening, following a 12-hour fasting
             period.

          -  Fasting blood glucose assessed with a glucose meter above 6.1 mmol/L approximately 0.5
             hour before each dosing.