MedTrace Logo

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

NCT07356713 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-19

No results posted yet for this study

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

Interventions

DRUG

Exl-111 (SAD)

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

DRUG

Exl-111 (MAD)

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

DRUG

Placebo

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

DRUG

Omalizumab

Omalizumab is administered by subcutaneous injection

Sponsors & Collaborators

  • Excellergy Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2026-12-07
Completion
2026-12-07

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07356713 on ClinicalTrials.gov