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

Primary Purpose

Celiac Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DONQ52
Placebo
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
  • Be on a GFD for at least 12 months
  • HLA-DQ2.5 genotype
  • Experienced at most mild symptoms of celiac disease

Exclusion Criteria:

  • Refractory celiac disease
  • Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)

Sites / Locations

  • Pinnacle Research GroupRecruiting
  • Diablo Clinical ResearchRecruiting
  • Jacksonville Center for Clinical ResearchRecruiting
  • Clinical Site Partners - OrlandoRecruiting
  • Velocity Clinical Research - BoiseRecruiting
  • Tandem Clinical ResearchRecruiting
  • Lucas Research - Diabetes & Endocrinology Consultants, PCRecruiting
  • North Carolina Clinical ResearchRecruiting
  • Aventiv Research, Inc.Recruiting
  • Velocity Clinical Research, AndersonRecruiting
  • Alliance for Multispecialty ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SAD Cohort 1

SAD Cohort 2

SAD Cohort 3

SAD Cohort 4

MAD Cohort 1

MAD Cohort 2

MAD Cohort 3

Arm Description

All randomized patients will receive one dose of either DONQ52 Dose A or placebo

All randomized patients will receive one dose of either DONQ52 Dose B or placebo

All randomized patients will receive one dose of either DONQ52 Dose C or placebo

All randomized patients will receive one dose of either DONQ52 Dose D or placebo

All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo

All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo

All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo

Outcomes

Primary Outcome Measures

Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Incidence and severity of TEAEs and its relationship to the study drugs
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Abnormality in vital signs
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Abnormality in Electrocardiograms (ECGs)
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Incidence of laboratory abnormalities, based on clinical laboratory tests

Secondary Outcome Measures

Pharmacokinetics; Serum DONQ52 concentration
Serum DONQ52 concentrations over time
Pharmacokinetics; Maximum serum concentration [Cmax]
Cmax of DONQ52
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Tmax of DONQ52
Pharmacokinetics; Area under the serum concentration time curve [AUC]
AUC of DONQ52
Pharmacokinetics; Half life [T1/2]
T1/2 of DONQ52
Immunogenicity
Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52

Full Information

First Posted
June 13, 2022
Last Updated
January 5, 2023
Sponsor
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05425446
Brief Title
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Official Title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAD Cohort 1
Arm Type
Experimental
Arm Description
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
Arm Title
SAD Cohort 2
Arm Type
Experimental
Arm Description
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
Arm Title
SAD Cohort 3
Arm Type
Experimental
Arm Description
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
Arm Title
SAD Cohort 4
Arm Type
Experimental
Arm Description
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
Arm Title
MAD Cohort 1
Arm Type
Experimental
Arm Description
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
Arm Title
MAD Cohort 2
Arm Type
Experimental
Arm Description
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
Arm Title
MAD Cohort 3
Arm Type
Experimental
Arm Description
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Intervention Type
Drug
Intervention Name(s)
DONQ52
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Description
Incidence and severity of TEAEs and its relationship to the study drugs
Time Frame
Up to 246 days
Title
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Description
Abnormality in vital signs
Time Frame
Up to 246 days
Title
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Description
Abnormality in Electrocardiograms (ECGs)
Time Frame
Up to 246 days
Title
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Description
Incidence of laboratory abnormalities, based on clinical laboratory tests
Time Frame
Up to 246 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics; Serum DONQ52 concentration
Description
Serum DONQ52 concentrations over time
Time Frame
Up to 246 days
Title
Pharmacokinetics; Maximum serum concentration [Cmax]
Description
Cmax of DONQ52
Time Frame
Up to 246 days
Title
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Description
Tmax of DONQ52
Time Frame
Up to 246 days
Title
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Description
AUC of DONQ52
Time Frame
Up to 246 days
Title
Pharmacokinetics; Half life [T1/2]
Description
T1/2 of DONQ52
Time Frame
Up to 246 days
Title
Immunogenicity
Description
Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52
Time Frame
Up to 246 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of medically diagnosed celiac disease based on biopsies and positive celiac serology. Be on a GFD for at least 12 months HLA-DQ2.5 genotype Experienced at most mild symptoms of celiac disease Exclusion Criteria: Refractory celiac disease Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical trials information
Phone
only use Email
Email
clinical-trials@chugai-pharm.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sponsor Chugai Pharmaceutical Co. Ltd
Organizational Affiliation
clinical-trials@chugai-pharm.co.jp
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site Partners - Orlando
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucas Research - Diabetes & Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Learn more about this trial

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

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