A Study to Find a Suitable Dose of Exl-111 for Further Research
brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants. The trials consists of 2 parts, as follows: Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo. Part B (MAD): Up to 3 dose cohorts, each with 10 participants, randomized into 3 arms: Exl-111, placebo, and an active comparator (omalizumab).
detailed description
Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants.
Part A : In all SAD cohorts, trial intervention will be administered as single SC injection on Day 1. Participants will remain in the clinic through Day 5 and will return to the clinic for multiple follow up visits through Day 141 (Week 20)/End of Study \[EOS\]). The trial may proceed to Part B if recommended by the Safety Monitoring committee (SMC) upon review of available Part A safety data as described below.
Part B: Part B may be initiated following approval by the SMC after the SMC meeting for SAD Cohort 3 in Part A, and SMC review of:
SAD cohort corresponding to the proposed MAD starting dose level and SAD cohort corresponding to the proposed dose above the MAD starting dose level Participants will remain in the clinic from Day -1 through Day 5 for the first dose, Days 28-31 for the second dose, Days 56-59 for the third dose, and Days 84-89 for the fourth dose. Following the last dose, participants will return to the clinic over multiple follow-up assessments through Day 196 (Week 28)/EOS, 16 weeks after the last dose.
official title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of Exl-111 in Healthy Participants