Ala Wai Phase 1 safety and tolerability study with 14 healthy participants

INTERVENTION: New formulation of zanamivir, AWP‐09VDB‐S, to be administered in a gastric resistant capsule. Participants will receive two doses in total. Each dose is 2 x capsules of 150mg (300mg total) in feed and fasted state. 4‐13 days washout between period 1 and 2 Compliance check of the mouth and hand at administration. FED Cohort: Participants in the fed period will be dosed following a high–fat, high‐calorie breakfast. These participants will be required to fast overnight for at least 10 hours until 30 minutes prior to their scheduled dosing times, when they will be given a standard high‐fat, high calorie breakfast which will be entirely consumed within 30 minutes. The breakfast will consist of two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes (1 serving or approximately 114 gm) and 240 mL of whole milk. Participants will fast for at least 4 hours following dosing. IP will be administered with 240 mil of water. No food is allowed for at least 4 hours post‐dose. Water can be consumed as desired except for one hour after drug administration. FASTED Cohort Participants : Following an overnight fast of at least 10 hours, participants will be administered IP with 240 mL of water. No food is allowed for at least 4 hours post‐dose. Water can be consumed as desired except for one hour before and after drug administration. CONDITION: the treatment and prophylaxis of influenza PRIMARY OUTCOME: Safety Assessments: This study assesses the safety and tolerability of AWP‐09VDB‐S under FED and FASTING conditions. Safety will be determined by evaluating physical examinations, ECGs, vital signs, clinical laboratory parameters, and AEs. If deemed necessary, additional safety measurements will be performed at the discretion of the PI and/or Sponsor. SECONDARY OUTCOME: To assess the pharmacokinetics (PK) of a single oral dose of AWP‐09VDB‐S when administered to healthy volunteers in the presence and absence of food. Pharmacokinetic profiles: Cmax, Tmax, AUClast, AUC0‐inf, Kel, t1/2 and CL/F computed from plasma zanamivir concentrations and Ae(t’‐t’’), Ae0‐24, Re, Rmax, and TRmax computed from the individual urine zanamivir concentrations. ; Urine PK smaples will be collected and refrigerated during the collection intervals. At the end of each interval, total urine volume will be measured, and an aliquot will be collected and stored frozen for PK analysis if deemed necessary by Ala Wai Pharma. INCLUSION CRITERIA: 1. Adult male and/or female healthy volunteers with a minimum age of at least 18 years and maximum age of 65 years at the time of screening. 2. Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam) as judged by the PI. 3. Negative urine drug screen /alcohol breath test prior to Day ‐1. 4. Availability of participant for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, Informed Consent Form. 5. If male, agrees to be sexually abstinent or to use a condom (with the female sexual partner also to use an effective method of contraception) when engaging in sexual activity from admission through completion of the end‐of study. Participants will be advised to use a condom (with the female sexual partner also to use an effective method of contraception) for 30 days following the last administration of the investigational product, an