A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of an Inhaled Antibody in Healthy Volunteers

ABSTRACT

ConditionCOVID-19;
COVID-19;Respiratory - Other respiratory disorders / diseases;Infection - Other infectious diseases

InterventionThis is a single centre, double-blind randomised placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of nebulised IN-006 in healthy volunteers.

The study will be enrolled in 3 cohorts. Subjects will only be allowed to enrol in one cohort.
1. 2 cohorts of single-ascending dose (SAD) cohorts The first cohort will enrol 8 subjects, randomised to receive a single low dose of IN-006 or placebo. In the second cohort, 8 subjects will be randomised to receive a single high dose of IN-006 or placebo.
2. The last cohort is a multiple-dose (MD) cohort where 8 subjects will be randomised to receive a daily dose of IN-006 or placebo for 7 days. The dose will be determined from the safety data from SAD.

All subjects will receive IN-006 or placebo via a nebulizer which will be administered by the study site staff while in the clinic.

A Dose Escalation Committee (DEC) will review the safety data of the first 24 hours of SAD Cohort 1 before proceeding to SAD Cohort 2. A second DEC meeting will review safety data through Day 8 of Cohort 1 and the first 24 hours of SAD COhort 2 to determine the dose that will be administered in the MD cohort.


Primary outcome:The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following a single dose of IN-006.

Safety and tolerability assessments will include vital signs (including FEV1 and SpO2), safety labs, ECG, and physical exams.[Vital signs including FEV1 and SpO2 will be collected at
Screening, Day -1 (the day prior to dosing), Dosing Day 1, Day 2 at 24 hours post-dose, Day 4 (72 hr), Day 6 (120 hr), Day 8 (168 hr), Day 15, and Day 29 (End Of Study [EOS]). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.

Safety labs will be collected at
Screening, Day -1 (the day prior to dosing), and post-dose on Day 2 (24 hours post-dose), Day 8 (168 hrs), and Day 29 (EOS).

ECGs will be collected at Screening, Day -1 (the day prior to dosing), Day 2 (24 hours post-dose), and Day 29 (EOS),

Complete physical exams will be completed at Screening, Day 2 (24 hours post-dose), and Day 29 (EOS), Symptom-directed exams may be conducted at any other time at the discretion of the investigator.

];The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following multiple doses of IN-006.

Safety and tolerability assessments will include vital signs (including FEV1 and SpO2), safety labs, ECG, and physical exams.[Vital signs including FEV1 and SpO2 will be collected at
Screening, Day -1 (the day prior to dosing), Dosing Days 1 through 7, Day 8, Day 15, and Day 29 (EOS). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.

Safety labs will be collected at
Screening, Day -1, and post-dose on Day 4 (72 hrs), Day 8 (168 hrs), Day 15, and Day 29.

ECGs will be collected at Screening, Day -1 (the day prior to dosing), and post-dose on Day 8, and Day 29 (EOS),

Complete physical exams will be completed at Screening, Day 8, and Day 29 (EOS), Symptom-directed exams may be conducted at any other time at the discretion of the investigator]

CriteriaInclusion criteria 1. Male and female, age 18-55 years, inclusive.
2. Non-smoker or smokes on average less than or equal to 10 cigarettes per week
3. Woman participants must be non-pregnant and either surgically sterile, use an acceptable contraceptive method, or be post-menopausal
4. Male participants must be surgically sterile, abstinent, or if engaged in sexual relations with a WOCBP, the partner must be surgically sterile or using an acceptable contraceptive method
5. Negative SARS-CoV-2 RT-PCR nasal swab during screening period




Exclusion criteria 1. Known or suspected symptomatic viral infection within 14 days of dosing initiation.
2. Signs of active pulmonary infection or pulmonary inflammatory conditions within 14 days of dosing.
3. History of hypersensitivity or allergies to a biologic drug or a constituent of the study drug or placebo.
4. History of previous administration of a monoclonal antibody or any inhaled biologic.
5. History of vaccination against SARS-CoV-2.
6. History of atopy or airway hyperresponsiveness.