CompletedPhase 1ACTRN12622001449729

A Randomized, Double-blind, Placebo-controlled Phase I Study of Subcutaneous EQ102 Administered in a Single and Multiple Ascending Dose Schedule

A Randomized, Double-blind, Placebo-controlled Phase I Study to assess the safety and tolerability of Subcutaneous EQ102 Administered in a Single and Multiple Ascending Dose Schedule.

Sponsor

Equillium AUS PTY Ltd

Enrollment

72 participants

Start Date

Sep 30, 2022

Study Type

Interventional

Conditions

Celiac Disease

Summary

This study is a First in Human, randomized, double-blind, placebo-controlled study of subcutaneous EQ102 administered as single (SAD) or multiple (MAD) doses. In Part A (SAD), up to approximately 48 healthy adult men and women will be enrolled and randomized to 6 cohorts (n=8 per cohort) to receive single ascending doses of EQ102 at doses of 50, 100, 200, 500, and up to 1000 mg or placebo. Dosing in each cohort for Part A will commence with two sentinel participants with one of the two sentinels randomized to receive EQ102 and the other randomized to receive placebo. EQ102 will be given in sequential, escalating doses contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). In Part B (MAD), healthy adult volunteers will be enrolled and randomized to 3 cohorts (n=8 per cohort) to receive multiple ascending doses of EQ102 or placebo. In Part B, up to three dose levels will be evaluated in healthy volunteers. The starting dose for Part B will be based on review of safety and PK data from Part A. The decision to escalate between dose levels will be based upon review of all safety and PK data.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria5

Males and females 18 to 55 years of age inclusive.
Body mass index (BMI) 18.0 to 32.0 kg/m2, with a body weight greater than or equal to 50 kg.
Medically healthy without clinically significant abnormalities.
Have suitable venous access for blood sampling
Additional vaccine requirements as outlined in the 'Public notes' field below

Exclusion Criteria12

History of chronic alcohol abuse or excessive alcohol intake within 12 weeks prior to screening.
History of substance abuse or drug addiction within 12 months prior to first study drug administration and positive drug test results.
History of relevant drug hypersensitivity.
Smoke more than 2 nicotine containing products or equivalent per week or who are not willing to abstain from smoking 7 days prior to admission and during the confinement period(s).
Use of systemic immunomodulatory or immunosuppressant treatments 1 month or 5 half-lives of the medication (whichever is longer) prior to screening. Topical or inhaled corticosteroids are acceptable.
Use of any prescription or over-the-counter medication (including herbal products) – exceptions include oral contraceptives, occasional use of ibuprofen, paracetamol, topical ointments, and vitamins or dietary supplements.
Receipt of any investigational drug within 1 month of screening.
Positive for HIV-1 or HIV-2, hepatitis B virus (HBV), or Hepatitis C virus (HCV)
Positive QuantiFERON TB Test.
Use of any live or live attenuated vaccinations within 30 days prior to the first study drug administration except for vaccines for influenza.
Donation or receipt of blood or blood products.
Regular, excessive consumption of caffeine-containing products.

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Interventions

This study is a First in Human, randomized, double-blind, placebo-controlled study of EQ102 administered via subcutaneous (SC) injection as single (SAD) or multiple (MAD) doses. In Part A (SAD), up t

This study is a First in Human, randomized, double-blind, placebo-controlled study of EQ102 administered via subcutaneous (SC) injection as single (SAD) or multiple (MAD) doses. In Part A (SAD), up to approximately 48 healthy adult men and women will be enrolled and randomized to 6 cohorts (n=8 per cohort) to receive single ascending doses of EQ102 SC at doses of 50, 100, 200, 500 or up to 1000 mg or placebo. Specific dose levels for each cohort will be agreed by SRC prior to commencement of dosing in that cohort. Additional Part A cohort(s) may be added to achieve the study's objectives with agreement by the SRC. Dosing in each cohort for Part A will commence with two sentinel participants with one of the two sentinels randomized to receive EQ102 SC and the other randomized to receive placebo SC. EQ102 will be given SC in sequential, escalating doses contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). In Part B (MAD), healthy adult volunteers will be enrolled and randomized to 3 cohorts (n=8 per cohort) to receive multiple ascending doses of EQ102 or placebo SC. In Part B, up to three dose levels will be evaluated in healthy volunteers. The starting dose for Part B will be based on review of safety and PK data from Part A. A single dose of EQ102 (or placebo) will be administered SC once per week, for a total of 4 weeks (4 doses of EQ102 or placebo SC). The decision to escalate between dose levels will be based upon review of all safety and PK data. Subcutaneous injection of EQ102 or placebo will be administered by clinical staff, per protocol. Adherence to the intervention will be done via completion of drug accountability.