A Phase 1, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of intravenously infused IB409 in healthy adult participants

This is a study of safety, tolerability and pharmacokinetics of a single ascending dose of IB409-001 in healthy volunteer participants. It is cohort designed with up to 6 cohorts of eight participants each, where 6 will receive IB409 and two will receive placebo as an intravenous injection. The dose escalation decisions between cohorts will be managed by a Safety Monitoring Committee (SMC). Eligibility will be assessed during a screening period of up to 28 days prior to dosing. For the treatment period, subjects will be admitted to the clinical research unit (CRU) one day prior to the dosing (Day -1). Randomisation will occur on the morning of dosing (Day 1). On Day 1, all subjects will receive an intravenous dose of IB409 or placebo. Participants will be discharged from the clinic on Day 3 after all required study procedures are completed and if deemed medically fit. Subjects will then return to the clinic on Day 7 (+1 day), on Day 15 (±1 day) for follow up visits and finally for an End of Study visit on Day 30 (±2 days). Up to 6 cohorts may be enrolled in the study. Five (5) single doses are planned to be tested in 5 cohorts (Cohort A1 to Cohort A5) of up to 8 healthy volunteers (up to 6 active and 2 placebo). An additional ascending dose level (Cohort A6), also consisting of up to 8 subjects (up to 6 active and 2 placebo), will be enrolled based on emerging safety, tolerability, and PK data. Additional cohorts may also be enrolled if deemed necessary by the SMC and Sponsor. The planned IB409 starting dose for this study is 0.01 mg per kg, administered as a single IV infusion over 40 minutes (± 10 minutes). All doses will be administered in clinic under the direct supervision of qualified study nurses and doctors. The anticipated dose range of IB409 for investigation in this study is 0.01 mg per kg up to 1.0 mg per kg. The following dose levels are currently planned for the study: • Cohort A1: 0.01 mg per kg IB409 or placebo • Cohort A2: 0.03 mg per kg IB409 or placebo • Cohort A3: 0.10 mg per kg IB409 or placebo • Cohort A4: TBD mg per kg IB409 or placebo • Cohort A5: TBD mg per kg IB409 or placebo Optional Cohort A6: TBD mg per kg IB409 or placebo Note: Currently, doses are confirmed for only the first 3 cohorts (A1 to A3), and the dose from cohorts A4 to A6 will be determined based on SMC review of cumulative SAD cohort safety and PK data of all previous cohorts. The highest dose that may be evaluated is 1.0 mg per kg of IB409. Sentinels will be used in all cohorts. Within each cohort, 2 subjects will be treated first: 1 subject will receive IB409 and 1 subject will receive placebo. Provided no clinically significant safety issues are noted at least in the 48 hours following the sentinels’ dosing, as judged by the Principal Investigator (PI) in consultation with the local medical monitor (MM) and Sponsor, if required, the remaining 6 subjects of the cohort can be dosed (5 active, 1 placebo). Safety Oversight : The study will be subject to oversight by an SMC comprised of the Principal Investigator (PI), independent local MM, and Sponsor medical representative as core members. The SMC will convene for each SAD dosing cohort to determine if dose escalation may proceed based on review of cumulative (blinded) data. Data from participants receiving placebo and active treatment will be considered in the dose escalation discussion. The dose escalation decision will be based upon the nature, severity and frequency of any safety and/or tolerability observations (up to and including the Day 7 visit), and the available PK data. The SMC may also pause the study to conduct an expert review and determine next steps. No intra-cohort dose escalation is permitted.