First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants

Summary

This is a 3-part, parallel group treatment, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics after sequential single and multiple ascending doses of SAR443765 in healthy adult participants, and after a single dose of SAR443765 in participants with mild-to-moderate asthma.

Timeline

Start

2022-06-08

Primary completion

2023-02-24

Completion

2023-02-24

Publications

• Results Deiteren A, Krupka E, Bontinck L, Imberdis K, Conickx G, Bas S, Patel N, Staudinger HW, Suratt BT. A proof-of-mechanism trial in asthma with lunsekimig, a bispecific NANOBODY molecule. Eur Respir J. 2025 Apr 24;65(4):2401461. doi: 10.1183/13993003.01461-2024. Print 2025 Apr.
• Deiteren A, Bontinck L, Conickx G, Vigan M, Dervaux N, Gassiot M, Bas S, Suratt B, Staudinger H, Krupka E. A first-in-human, single and multiple dose study of lunsekimig, a novel anti-TSLP/anti-IL-13 NANOBODY(R) compound, in healthy volunteers. Clin Transl Sci. 2024 Jun;17(6):e13864. doi: 10.1111/cts.13864.

Drugs

Indications