Actively Recruiting
A Study to Find a Suitable Dose of Exl-111 for Further Research
Led by Excellergy Inc. · Updated on 2026-02-19
70
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Find a Suitable Dose of Exl-111 for Further Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 to 55 at screening
- Body weight between 45 kg and 120 kg and BMI between 18 and 32 kg/m2 at screening and Day -1
- Serum IgE levels between 30 and 300 IU/mL at screening
- Nonsmoker or smoking no more than 2 cigarettes or equivalent per week
- Positive skin prick test to common aeroallergens (for Part B participants only)
- Willing and able to read, understand, and sign informed consent
You will not qualify if you...
- Previous participation receiving Exl-111 in this trial
- Prior use of any anti-IgE therapy
- Use of any medication within 5 days before dosing through 30 days after last dose, except approved by investigator
- Participation in another trial with investigational agent within 30 days or 5 half-lives before Day 1
- Use of protein or antibody-based therapies within 3 months before screening
- Receipt of live vaccines within 12 weeks or non-live vaccines within 4 weeks before screening
- Active systemic infection within 30 days before Day 1
- Positive tests for hepatitis B, hepatitis C, HIV, or tuberculosis at screening
- Current treatment for allergies except OTC antihistamines for seasonal allergies
- Use of drugs interfering with skin prick tests within 5 days before testing (Part B only)
- History of significant allergic reactions or drug hypersensitivity
- History of cardiac arrhythmia or risk factors for Torsades de Pointes
- Clinically significant diseases judged by investigator
- History of cancer within 5 years
- History of alcohol or substance abuse in past 5 years
- History of vasovagal reactions or hereditary alpha-tryptasemia
- Positive drug or alcohol tests at screening or Day -1
- Abnormal laboratory safety tests considered clinically significant
- Elevated liver enzymes or bilirubin at screening
- Reduced kidney function (eGFR <60 mL/min/1.73m2)
- High blood pressure above specified limits
- Abnormal ECG findings including prolonged QTc or QRS duration
- Pregnancy, breastfeeding, or planning pregnancy during study and 30 days after
- Unwillingness or inability to comply with contraception and lifestyle restrictions
- Employment by sponsor or site or related to site employee
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
R
Reza Pishva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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