A Study to Find a Suitable Dose of Exl-111 for Further Research
ConditionAllergic Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorExcellergy Inc.
About this trial
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).
Eligibility criteria
Qualifiers
Healthy, male and female participants 18-55 years of age at Screening
Body weight ≥45 kg and ≤120 kg and body mass index (BMI) 18 to ≤32 kg/m2 at Screening and Day -1
Serum IgE ≥30 IU/mL and ≤300 IU/mL at Screening
Nonsmoker and must not have used any tobacco products within 2 months prior to Screening. Participants who smoke ≤2 cigarettes or equivalent (e.g., cigars, vaping, nicotine patches) per week can be included in the trial at the discretion of the PI/delegate
Disqualifiers
Received Exl-111 in a prior cohort in this trial
Prior receipt of any anti-IgE therapy
Use of any medication, including any prescription, over-the-counter, or other supplements, within 5 days prior to dosing, extending to 30 days after last dose of trial intervention, with the exception of those approved by the PI and Sponsor or Sponsor representative.
Receipt of any small molecule investigational agent or trial intervention in a clinical trial within 30 days or 5 half-lives (whichever is longer) prior to Day 1
Trial design
Treatments tested in this trial
- Exl-111 (SAD)
- Exl-111 (MAD)
- Placebo
- Omalizumab
Treatment groups
70 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov