Santa Ana Bio
SAB01 is an investigational bispecific monoclonal antibody targeting mast cells. This first-in-human Phase 1 clinical trial evaluates the safety, pharmacokinetics, and pharmacodynamics of single ascending doses of SAB01 in healthy adult participants.
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SAB01 administered subcutaneously (SC) and intravenously (IV) in healthy participants. The design comprises 7 planned cohorts (6 SC and 1 IV) and up to 4 optional cohorts (up to 3 additional SC and up to 1 additional IV) for up to a maximum of 88 participants enrolled. The Safety Review Committee will oversee dose escalation. Within each cohort, 8 participants will be randomized 6:2 to SAB01 or plac…
Inclusion Criteria: 1. Provision of signed and dated ICF. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Healthy adult male or female aged at least 18 years but not older than 55 years. 4. Body mass index (BMI) within 18.0 to 32.0 kg/m2 inclusive, and up to a maximum body weight of 100 kg at Screening. 5. Non- or ex smokers. Participants must not have used any tobacco products within 6 months prior to Screening. Participants who have discontinued smoking or the use of nicotine or nicotine-containing products for at least 3 months p…
Single-dose administration of SAB01 by SC administration.
Intravenous doses of SAB01 via IV infusion.
Single-dose of placebo by subcutaneous (SC) administration.
Placebo administration via IV infusion.
Arctuva estimate
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