AyuVis Research, Inc.
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
This is a Phase 1, 2-part, double-blinded, placebo-controlled, randomized SAD/MAD study. The study will include 2 parts: * Part A: SAD phase * Part B: MAD phase Part A - SAD phase Healthy adult subjects will be randomized to receive a single IV dose of either AVR-48 or placebo in each of 3 planned SAD cohorts. Each cohort will consist of 8 subjects in a 3:1 (active:placebo) ratio to have a total of 6 subjects receiving AVR-48 and 2 subjects receiving placebo. Each cohort will be comprised of 50% male and 50% female subjects. All SAD cohorts will be dosed according to a sentinel dosing desi…
Inclusion Criteria: 1. Provision of signed and dated informed consent form (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 18 to 55, inclusive, at Screening. 4. Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study 5. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening, and a minimum weight of at least 50.0 kg and a maximum weight of 100.0 kg at screening. 6. Medically healthy…
Investigational drug reconstituted in normal saline will be administered via IV
Normal saline will be administered via IV
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