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

NCT07356713 | Recruiting Phase 1

• 1 other identifier: Exl-111.101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Allergic Disease

Outcome Measures

Primary Outcomes (1)

• Incidence 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

  From first dose through Day 196.

Secondary Outcomes (9)

• Pharmacokinetic assessment of maximum observed plasma concentration (Cmax) of Exl-111

  From treatment Day 1 to EOS/ET Week 20.

• Pharmacokinetic assessment of Time to Maximum Concentration (Tmax) of Exl-111

  From treatment Day 1 to EOS/ET Week 20.

• Pharmacokinetic assessment apparent Terminal Half-life (t1/2) of Exl-111

  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)

  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)

  From treatment Day 1 to EOS/ET Week 20.

Study Arms (4)

Exl-111 (SAD)

EXPERIMENTAL

Healthy participants receive a single subcutaneous dose of Exl-111 at 5 ascending dose levels

Drug: Exl-111 (SAD)

Exl-111 (MAD)

EXPERIMENTAL

Healthy participants receive Exl-111 at 3 ascending dose levels administered every 4 weeks (Q4W) for a total of 4 doses

Drug: Exl-111 (MAD)

Placebo

EXPERIMENTAL

Participants receive placebo injections matched in appearance and schedule to Exl-111: a single SC dose in Part A (SAD) or SC doses Q4W x4 in Part B (MAD), according to their assigned cohort.

Drug: Placebo

Comparator

EXPERIMENTAL

(MAD) Healthy participants receive omalizumab injections every 4 weeks (Q4W) for a total of 4 doses

Drug: Omalizumab

Interventions

Placebo DRUG

A placebo matched in appearance and route of administration to Exl-111 is given by subcutaneous injection

Placebo

Omalizumab DRUG

Omalizumab is administered by subcutaneous injection

Comparator

Exl-111 (MAD) DRUG

Exl-111 is administered by subcutaneous injection in ascending dose levels.

Exl-111 (MAD)

Exl-111 (SAD) DRUG

Exl-111 is administered by subcutaneous injection in a single dose.

Exl-111 (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Positive skin prick test at Screening (Part B MAD Cohorts only) to common aeroallergens
• Willing and able to read, understand, and sign an informed consent form (ICF) that includes compliance with requirements and restrictions listed in the ICF and in this protocol

You may not qualify if:

• 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
• Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or mAbs) within 3 months or 5 half-lives (whichever is longer) prior to Screening
• Receipt of either of the following:
• Any live/unattenuated vaccinations within 12 weeks prior to Screening
• Non-living/attenuated vaccinations (including inactivated vaccines, messenger RNA vaccines) within 4 weeks prior to Screening
• History of active systemic infection within 30 days prior to Day 1
• Known history of positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV)-1 or HIV-2
• Positive test at Screening for HBsAg, hepatitis B core antibody (HBcAb), HCV Ab, HIV antibody, QuantiFERON®-TB Gold In-Tube test
• In Part B only, use of any drug that may interfere with the skin prick test results, including antihistamine use within 5 days before each skin prick test
• History of relevant drug hypersensitivity, or any confirmed significant allergic reactions (urticaria or anaphylaxis), as judged by the PI, against any drug, or multiple drug or food allergies.
• History of cardiac arrhythmia or family history of sudden cardiac death or a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, hypomagnesia, or family history of Long QT Syndrome)
• Clinically relevant history of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders that, in the opinion of the PI, might pose additional risk to the participant or confound the results of the trial

Sponsors & Collaborators

• Excellergy Inc.: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Interventions

Sagittal Abdominal Diameter; mycophenolic adenine dinucleotide; Omalizumab

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Reza Pishva

CONTACT

+61731376258; reza.pishva@novotech-cro.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 21, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)