A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteers
Thomas R Moench, Lakshmi Botta, Brian Farrer, Jason D Lickliter, Hyunah Kang, Yoona Park, Cheolmin Kim, Marshall Hoke, Miles Brennan, Morgan D Mcsweeney, Zachary Richardson, John B Whelan, Jong Moon Cho, Soo Young Lee, Frances Faurot, Jeff Hutchins, Samuel K Lai
eBioMedicine, doi:10.1016/j.ebiom.2025.105582
Background Although COVID-19 is predominantly a respiratory tract infection, current antibody treatments are administered by systemic dosing. We hypothesize that inhaled delivery of a monoclonal antibody may be a more effective and convenient route. We investigated the safety, tolerability, and pharmacokinetics of IN-006, a reformulation of regdanvimab for nebulized delivery by a handheld nebulizer. Methods A Phase 1 study was conducted in healthy volunteers aged 18-55 a Phase 1 unit in Melbourne, Australia (ACTRN12621001235897). Study staff and participants were blinded to treatment assignment, except for pharmacy staff preparing the study drug. The ratio of active:placebo randomization to each cohort was set at 3:1. The primary outcomes were safety and tolerability. Exploratory outcomes were pharmacokinetics of IN-006 in nasal fluid and serum. Findings Twenty-three participants were enrolled and randomized across two single dose and one multiple dose cohorts (30 mg or 90 mg single nebulized dose, or seven daily 90 mg doses). There were no serious adverse events. All enrolled participants completed the study without treatment interruption or discontinuation. All treatmentemergent adverse events were transient, non-dose dependent, and graded mild to moderate in severity. Nebulization was well-tolerated and completed in an average of 6 min. Geometric mean nasal fluid concentrations of IN-006 in the multiple dose cohort were 739.8 μg/mL at 30 min after dosing and 1.2 μg/mL at 22 h. Geometric mean serum levels in the multiple dose cohort peaked at 0.51 μg/mL 3 days after the final dose. Interpretation IN-006 was well-tolerated and achieved concentrations in the respiratory tract orders of magnitude above the IC 50 range typical of antiviral mAbs. These data support further development of nebulized delivery of antiviral mAbs for respiratory infectious disease.
The academic authors and the authors who are employees of the sponsor vouch for the accuracy and completeness of the data, the statistical analysis, and the fidelity of the study to the protocol.
Data sharing statement Deidentified data from this study will be made available from the corresponding author upon reasonable request. Reagents related to this study may be available upon reasonable request submitted to the corresponding author, pending availability. Some reagents associated with this study, including IN-006, are no longer clinically available and therefore cannot be shared.
Declaration of interests TM, LB, BF, MH, MB, MM, ZR, JW, FF, and JH are employees of Inhalon Biopharma/Mucommune and may hold shares in Inhalon Biopharma, Inc. HK, YP, CK, JMC, and SYL are employees of Celltrion, Inc, which received funding from the government of Korea to advance Regdanvimab, which was used to cover salary for their work on this project. JL received partial salary support for his work on this project. SKL is founder of Mucommune, LLC and currently serves as its interim CEO. SKL is also founder of Inhalon Biopharma, Inc, and currently serves as its CSO as well as on its Board of Director and Scientific Advisory Board. S.K.L has equity interests in both Mucommune and Inhalon Biopharma; S.K.L's relationships with Mucommune and Inhalon are subject to certain restrictions under University policy. The terms of these arrangements are managed by UNC-CH in accordance with its conflict..
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