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

Sponsor
Excellergy Inc.
Study ID
NCT07356713
Phase
PHASE1
Status
Recruiting
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Conditions

  • Allergic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Exl-111 (SAD) — DRUG
    Exl-111 is administered by subcutaneous injection in a single dose.
  • Exl-111 (MAD) — DRUG
    Exl-111 is administered by subcutaneous injection in ascending dose levels.
  • Placebo — DRUG
    A placebo matched in appearance and route of administration to Exl-111 is given by subcutaneous injection
  • Omalizumab — DRUG
    Omalizumab is administered by subcutaneous injection

Study Details

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).

Key Dates

Start date
Jan 8, 2026
Status verified
Feb 2026
Primary completion
Dec 7, 2026
Completion
Dec 7, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Exl-111 (SAD)
    Healthy participants receive a single subcutaneous dose of Exl-111 at 5 ascending dose levels
  • Experimental: Exl-111 (MAD)
    Healthy participants receive Exl-111 at 3 ascending dose levels administered every 4 weeks (Q4W) for a total of 4 doses
  • Experimental: Placebo
    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.
  • Experimental: Comparator
    (MAD) Healthy participants receive omalizumab injections every 4 weeks (Q4W) for a total of 4 doses

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events and serious adverse events for Part A and Part B [ Time Frame: From first dose through Day 196. ]

Central Contacts