A randomized, placebo-controlled, sequential, participant- and Investigator-masked Phase 1 study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics ( PD) of ascending single and multiple doses of SAR446422 in female and male healthy participants 18 to 55 years of age

Sanofi-Aventis Australia Pty Ltd0 个研究点目标入组 120 人开始时间: 2023年11月14日最近更新: 2024年8月5日

适应症

试验速览

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•Participants who are overtly healthy as determined by medical evaluation including medical/surgical history, physical examination, laboratory tests, and cardiac monitoring. Body weight between 50.0 and 110.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, BMI between 18.0 and 32.0 kg/m2, inclusive.
•A female participant not pregnant or breastfeeding, and one of the following conditions applies:
•-- Is a woman of non-child-bearing potential (WONCBP) or
•-- Is a woman of child-bearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective
•--A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulation) within 36 hours before the first administration of study intervention.
•Male participants who agree to:
•-- refrain from donating sperm;
•-- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent;
•--Must agree to use contraception/barrier.

•Participants are excluded from the study if any of the following criteria apply:
•-Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), immunological or infectious disease, or signs of acute illness.
•- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Anaphylaxis from any cause. Known hypersensitivity to any component of the IMP formulation. Previous exposure to KLH or hypersensitivity to shellfish. History of mild, controlled allergy may be included at Investigator’s discretion.
•- Any immunization with a non-live vaccine, including against COVID-19, within 4 weeks of enrollment (SAD study Cohort 1 and 2, MAD study) or within 2 weeks of enrollment (SAD study Cohort 3 and higher).
•- Any immunization with a live vaccine within 3 months of enrollment.
•- Symptomatic herpes zoster within 3 months prior to Screening.
•- History of recurrent oral or genital herpes.
•- Evidence of active or latent TB as documented by medical history and examination, chest X-rays or a positive QuantiFERON-TB Gold Plus test.
•- History of invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis, irrespective of resolution.

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