What is Exl-111 studying for allergic disease?

Exl-111 is being studied to find suitable dosing levels in healthy adults for future research on allergic disease. This Phase 1 trial evaluates the safety and how the body processes the drug compared to placebo and omalizumab. It is sponsored by Excellergy Inc. to better understand Exl-111's effects before further testing.

Who may be eligible for this allergic disease clinical trial?

Adults aged 18 to 55 who are healthy and meet weight and body mass index requirements may be eligible. Participants must have specific IgE levels and not be current smokers beyond a low threshold. People with prior anti-IgE therapy or certain medical conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this allergic disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 18Years - 55Years

All Genders

Healthy Volunteers

ID07356713

Phase 1 Study Testing Different Doses of Exl-111 in Healthy Adults Aged 18 to 55

Led by Excellergy Inc. · Updated on 2026-02-19

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Exl-111, a drug studied in a Phase 1 trial involving healthy adults aged 18 to 55. The trial aims to find suitable doses for future research by studying single and multiple ascending doses. It includes two parts a single ascending dose SAD phase and a multiple ascending dose MAD phase. The study also compares Exl-111 with placebo and an active comparator called omalizumab. Participants are healthy volunteers with allergic disease markers but no active illness. In Part A SAD, participants receive a single subcutaneous injection of Exl-111 or placebo and stay in the clinic for 5 days, with follow-up visits through 20 weeks. If safety data supports it, Part B MAD begins, where participants receive up to four subcutaneous doses of Exl-111, placebo, or omalizumab every 4 weeks. Participants stay in the clinic for several days around each dose and return for follow-up visits through 28 weeks. Throughout the study, participants undergo safety monitoring for adverse events and pharmacokinetic testing to assess drug levels in the blood. The primary outcome measures include treatment-emergent adverse events through Day 196. Secondary measures assess how the body absorbs and processes Exl-111. Participants complete clinic visits, safety labs, skin prick tests Part B only, and other assessments to track effects and safety over the full duration of the trial.

CONDITIONS

Brief Title

A Study to Find a Suitable Dose of Exl-111 for Further Research

Who Can Participate

Age: 18Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy male and female participants aged 18 to 55 years at screening
Body weight between 45 kg and 120 kg and body mass index between 18 and 32 kg/m2 at screening and Day -1
Serum IgE levels between 30 IU/mL and 300 IU/mL at screening
Non-smokers or smoking fewer than 2 cigarettes or equivalent per week (at investigator discretion)
Positive skin prick test to common aeroallergens (required for Part B MAD cohorts only)
Willing and able to read, understand, and sign informed consent and comply with trial requirements

You will not qualify if you...

Received Exl-111 in a prior cohort of this trial
Prior use of any anti-IgE therapy
Use of any medication within 5 days before dosing until 30 days after last dose except those approved by investigator or sponsor
Participation in another clinical trial with small molecule agents within 30 days or 5 half-lives prior to Day 1
Use of protein or antibody-based therapies within 3 months or 5 half-lives prior to screening
Recent live vaccinations within 12 weeks or non-live vaccinations within 4 weeks prior to screening
Active systemic infection within 30 days before Day 1
Positive test for hepatitis B, hepatitis C, HIV, or tuberculosis at screening
Active treatment for allergic conditions except allowed over-the-counter antihistamines
Use of drugs interfering with skin prick test within 5 days before tests (Part B only)
History of significant allergic reactions or multiple drug/food allergies
History or risk factors for cardiac arrhythmia or sudden cardiac death
Clinically relevant history of serious diseases or disorders that may increase risk or affect results
History of malignancy in past 5 years
History of alcohol or substance use disorder within past 5 years
History of vasovagal reactions or hereditary alpha-tryptasemia
Positive drug or alcohol tests at screening or Day -1
Clinically significant abnormal lab results or vital signs out of range at screening or Day -1
Pregnant, lactating, breastfeeding, or planning pregnancy during trial or within 30 days after last dose
Unwilling or unable to comply with contraception and lifestyle restrictions
Employee or relative of employee at sponsor or trial site involved in the study

Research Team

Reza Pishva

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