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

Conditions

None listed

Brief summary

This Phase 1a study will be a randomized, placebo-controlled, double-blind, single-center, ascending dose, first in human trial of an inhaled antibody vs. placebo in normal, healthy volunteer (NHV) men and women. The study will assess safety and pharmacokinetics, in initial single ascending doses (SAD) portion, followed by a multiple dose cohort..

Moench TR, Botta L, Farrer B, Lickliter JD, Kang H, Park Y, Kim C, Hoke M, Brennan M, McSweeney MD, Richardson Z, Whelan JB, Cho JM, Lee SY, Faurot F, Hutchins J, Lai SK.

2025-02-081 citations

10.1016/j.ebiom.2025.105582

Interventions

This 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 hi

This 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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.

Outcome results