Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of Exl-111 in Healthy Participants
Led by Excellergy Inc. · Updated on 2026-02-19
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 weeks depending on cohort and part
Participants receive Exl-111 or placebo by subcutaneous injection. In Part A, participants receive a single dose and remain in the clinic through Day 5 with multiple follow-up visits until Week 20. In Part B, participants receive up to 4 doses every 4 weeks with clinic stays around dosing days and follow-up visits until Week 28.
In Part A, participants stay in the clinic from Day 1 to Day 5 with multiple follow-up visits through Week 20; in Part B, participants stay in the clinic for dosing periods (Day -1 to 5, Days 28-31, 56-59, 84-89) with follow-up visits through Week 28
Trial Site Locations
Total: 1 location
1
CMAX
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
R
Reza Pishva
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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