Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Chugai Pharmaceutical
Study ID
NCT05425446
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • DONQ52 — DRUG
    Subcutaneous (SC) injection
  • Placebo — DRUG
    Subcutaneous (SC) injection

Study Details

This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.

Key Dates

Start date
Sep 19, 2022
Status verified
Jan 2025
Primary completion
Aug 9, 2024
Completion
Jan 17, 2025

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD Cohort 1
    All randomized patients will receive one dose of either DONQ52 Dose A or placebo
  • Experimental: SAD Cohort 2
    All randomized patients will receive one dose of either DONQ52 Dose B or placebo
  • Experimental: SAD Cohort 3
    All randomized patients will receive one dose of either DONQ52 Dose C or placebo
  • Experimental: SAD Cohort 4
    All randomized patients will receive one dose of either DONQ52 Dose D or placebo
  • Experimental: MAD Cohort 1
    All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
  • Experimental: MAD Cohort 2
    All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
  • Experimental: MAD Cohort 3
    All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher [ Time Frame: Up to 246 days ]

Locations (18)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-
Mountain View Clinical ResearchDenverColorado80209-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Clinical Site PartnersLeesburgFlorida34748-
Clinical Site Partners - OrlandoWinter ParkFlorida32789-
Velocity Clinical Research - BoiseMeridianIdaho83642-
Tandem Clinical ResearchMarreroLouisiana70072-
Mayo Clinic - RochesterRochesterMinnesota55095-
Long Island Gastrointestinal Research GroupGreat NeckNew York11023-
Columbia University Medical CenterNew YorkNew York10019-
Lucas Research - Diabetes & Endocrinology Consultants, PCMorehead CityNorth Carolina28557-
North Carolina Clinical ResearchRaleighNorth Carolina27607-
Aventiv Research, Inc.ColumbusOhio43213-
Digestive Specialists IncDaytonOhio45414-
Velocity Clinical Research, AndersonAndersonSouth Carolina29621-
Alliance for Multispecialty ResearchKnoxvilleTennessee37920-
Digestive Research of Central TexasWacoTexas76712-
Care Access ResearchOgdenUtah84403-

Find similar trials in Anniston, AL

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
Pinnacle Research Group· Anniston, ALMountain View Clinical Research· Denver, COJacksonville Center for Clinical Research· Jacksonville, FLClinical· Leesburg, FLClinical Site Partners - Orlando· Winter Park, FLVelocity Clinical Research - Boise· Meridian, ID

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