Phase 1 study

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

• Male and female adults aged > 18 and < 65 years at screening

• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a maximum body weight of 120 kg at screening

• General good health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion

• Willing and able to comply with all study activities, assessments, and restrictions through 28 days of follow-up, have provided written informed consent to participate in the clinical trial before any study-related activities are carried out, and, in the PI's opinion, able to understand the full nature and purpose of the trial, including possible risks and adverse effects

• Subjects of child-bearing potential use effective contraception from screening through 12 weeks after study dosing.

  • Female volunteers must:

    • Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level >40 IU/L at the screening visit), or
    • If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.

  • Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug

Exclusion Criteria:

• History or presence of clinically significant medical condition or disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease
• Any acute illness or surgery within the past 12 weeks prior to screening determined by the PI to be clinically relevant
• Known allergy or previous anaphylaxis to any components of the study product
• Allergies, a history of allergic conditions, nasal or sinus conditions, upper respiratory conditions, or chronic respiratory conditions, including seasonal allergies and mild asthma (history of childhood asthma or childhood allergies are not exclusionary)
• History of nasal or upper respiratory pathology or abnormalities
• Ongoing (within 28 days of study product administration through end of follow-up) use of nasal spray or drops and/or use of any intranasal spray or drops and/or inhaled product within 28 days prior to study drug administration.'
• Ongoing (within 28 days of study product administration through end of follow-up) or planned treatment with immunomodulator or immunosuppressant agents or medicines (including over the counter, herbal and prescription drugs and supplements with significant activity in the respiratory tract)
• Treatment with an investigational device or compound within 30 days or 5 half-lives (whichever is longer) prior to study product administration
• Current or planned pregnancy or breastfeeding/lactating
• Tobacco or nicotine use from screening through 28 days of study product administration
• Unable or unwilling to provide adequate informed consent