Health TrialsbyHealthPanel

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

ConditionAllergic Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorExcellergy Inc.

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 4 treatment groups
Group A: Exl-111 (SAD)Experimental treatment 1 intervention
Group B: Exl-111 (MAD)Experimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention
Group D: ComparatorExperimental treatment 1 intervention

Trial outcomes

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

Time frame
From first dose through Day 196.

Secondary outcomes

1

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

Maximum plasma concentration (Cmax)

Time frame
From treatment Day 1 to EOS/ET Week 20.
2

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

Time to Maximum Concentration (Tmax)

Time frame
From treatment Day 1 to EOS/ET Week 20.
3

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

Terminal Half-life (t1/2)

Time frame
From treatment Day 1 to EOS/ET Week 20.
4

Pharmacokinetic assessment observed volume of distribution associated with the terminal slope following administration of Exl-111. ( VZO)

Volume of distribution ( VZO)

Time frame
From treatment Day 1 to EOS/ET Week 20.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Excellergy Inc.

Lead sponsor

Source ClinicalTrials.gov
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