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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Exl-111 is administered by subcutaneous injection in a single dose.
Exl-111 is administered by subcutaneous injection in ascending dose levels.
A placebo matched in appearance and route of administration to Exl-111 is given by subcutaneous injection
CMAX
Adelaide, South Australia, Australia
RECRUITINGNew Zealand Clinical Research OPCO Ltd
Auckland, New Zealand
NOT_YET_RECRUITINGIncidence and severity of treatment-emergent adverse events and serious adverse events for Part A and Part B
This is to evaluate the safety and tolerability of single and multiple dose administration of Exl-111 in healthy participants
Time frame: From first dose through Day 196.
Pharmacokinetic assessment of maximum observed plasma concentration (Cmax) of Exl-111
Maximum plasma concentration (Cmax)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment of Time to Maximum Concentration (Tmax) of Exl-111
Time to Maximum Concentration (Tmax)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment apparent Terminal Half-life (t1/2) of Exl-111
Terminal Half-life (t1/2)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment observed volume of distribution associated with the terminal slope following administration of Exl-111. ( VZO)
Volume of distribution ( VZO)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment area under the curve (AUC) from the time of dosing to the last measurable concentration of Exl-111. (AUCLST)
Area Under the Curve (AUC)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration of Exl-111. (AUCIFO)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Omalizumab is administered by subcutaneous injection
Area under the curve (AUC) based on the last observed concentration. (AUCIFO)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) extrapolated to t from dosing time, based on tau of Exl-111. (AUCT)
Area Under the Curve Over the Dosing Interval (AUCT) Assessment
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the maximum concentration occurring at Tmax, divided by the dose of Exl-111. (CMAXD)
Dose-Normalized Maximum Plasma Concentration (Cmax/D)
Time frame: From treatment Day 1 to EOS/ET Week 20.
Pharmacokinetic assessment the area under the curve (AUC) for the defined interval between doses (TAU) divided by the dose of Exl-111. (AUCTAUD)
Pharmacokinetic assessment the area under the curve (AUC) for the defined interval Dose-Normalized Area Under the Curve Over the Dosing Interval (AUCTAUD)
Time frame: From treatment Day 1 to EOS/ET Week 20.