Obstructive sleep apnoea Nervous System Diseases
Conditions
Interventions
This is a pharmacoscintigraphic open-label crossover study.
Treatment 1 (Placebo): 2 administrations of 100 µL (one spray in each nostril of one of the diluents used in active treatment)
Treatment
Sponsors
Mosanna Therapeutics
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: Males and females, aged between 18 and 65 years inclusive 2. Weight & Body mass index (BMI): BMI between 18.0 and 32.0 kg/m², inclusive, and a body weight = 50 kg 3. Compliance: Understands and is willing, able, and likely to comply with all study procedures and restrictions 4. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. 5. General health: Healthy (as determined by the Investigator) based upon the results of a medical history, physical examination (including nasal exam), vital signs, 12-lead ECG and clinical laboratory safety tests 6. Administration of Nasal Spray: Demonstrates ability to use nasal administration device at screening visit as assessed by investigator 7. Family Planning/Contraception: 7.1. Male Participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 90 days after the last dose of study intervention: 7.1.1. Refrain from donating sperm PLUS, either: 7.1.2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR 7.1.3. Must agree to use a male condom alongside female partner use of an additional highly effective contraceptive method with a failure rate of < 1% when having sexual intercourse with a woman of childbearing potential who is not currently pregnant 7.2. Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 7.2.1. Is a woman of non-childbearing potential (WONCBP) OR 7.2.2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), with low user dependency during the study intervention period and at least until the follow-up visit of the study 7.2.3. Female participants must refrain from egg donation during the study intervention period and at least until the follow-up visit of the study
Exclusion criteria
Exclusion criteria: 1. Medical History: 1.1. Current or recurrent disease/condition that, in the opinion of the investigator, could affect study conduct; the safety of the participant because of participation; and/or the ability of the participant to complete the study or laboratory assessments (including but not exclusively a history of hay fever, rhinitis, asthma, syncope or hypertension) 1.2. Current or relevant previous history of severe or unstable psychiatric illness, that may require treatment or make the participant unlikely to fully complete the study, or that presents undue risk from the study medication or procedures 1.3. Having any illness (e.g., active allergy, fever, hypersensitivity reaction) judged by the investigator as clinically significant in the 3 months prior to first dosing of MOS-118 1.4. Haematological or biochemical blood test at screening outside normal ranges and deemed clinically significant by the PI or medically qualified designee 1.5. Clinically significant physical examination or clinically significant investigations (including those performed at screening and during treatment arm), deemed by the investigator to render the volunteer unfit for the study 1.6. Measured body temperature >38°C (at screening or dosing visit) 1.7. Any history of the following: 1.7.1. Rhinitis (on or off therapy) and/or stuffy nose in the 2 weeks prior to first dosing 1.7.2. Nasal surgery within 3 months of first dosing 1.7.3. Nasal obstruction impacting delivery 1.7.4. Active chronic sinusitis 1.7.5. Nasal polyps requiring surgical intervention 1.7.6. Significant septal deviation 1.7.7. Active nasal or sinus infection or mucosal inflammation 1.7.8. History of asthma or chronic rhinitis as an adult 1.7.9. Anatomical abnormalities requiring surgery which may impact intranasal delivery 1.8. Positive serology suggestive of acute or chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (Hep B) (HBsAg positive) or Hepatitis C Virus (HCV) 1.9. History of hepatitis from any cause, except for hepatitis A, that was resolved within 3 months prior to first dose of MOS-118 1.10. History of significant cardiac pathology or clinically significant abnormality on ECG, in the opinion of the investigator, or corrected QT interval (as calculated by Fridericia formula) on 12-lead ECG as defined by QTc = 450 (females) and 430 (males) msec 2. Medications 2.1. Use of nasal sprays, rinses or douches in the 2 weeks prior to first and/or any subsequent dose of MOS-118 2.2. Participant is scheduled to take prescribed medication within 14 days (or 5 half-lives – whichever is longer) prior to the first dose of MOS-118 which, in the opinion of the investigator, will interfere with the study procedures or compromise safety 2.3. Participant is scheduled to take over-the-counter (OTC) medication, including vitamins, pro and prebiotics and natural or herbal remedies, within 48 hours prior to the first dose of MOS-118 unless approved by the investigator 3. Alcohol/Substance Abuse 3.1. Recent history (within the last year) of alcohol or other substance abuse 3.2. Previous regular/habitual use of inhaled recreational drugs 3.3. Participants have an average weekly alcohol intake of greater than 14 units 3.4. Participant has a positive urine drugs of abuse test at screening or prior to dosing evaluation 3.5. Participant has a positive breath alcohol test at screening or prior to dosing evaluation (breath testing may be repeated once
Countries
Scotland, United Kingdom
Contacts
Public ContactLyn Corry
Outcome results
None listed