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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose A or placebo |
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| SAD Cohort 2 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose B or placebo |
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| SAD Cohort 3 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose C or placebo |
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| SAD Cohort 4 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose D or placebo |
|
| MAD Cohort 1 | Experimental | All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo |
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| MAD Cohort 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DONQ52 | Drug | Subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 246 days |
| Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation) | Abnormality in vital signs | Up to 246 days |
| Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate) | Abnormality in Electrocardiograms (ECGs) | Up to 246 days |
| Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis) | Incidence of laboratory abnormalities, based on clinical laboratory tests | Up to 246 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics; Serum DONQ52 concentration | Serum DONQ52 concentrations over time | Up to 246 days |
| Pharmacokinetics; Maximum serum concentration [Cmax] | Cmax of DONQ52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co. Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Mountain View Clinical Research |
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).
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All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo |
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| MAD Cohort 3 | Experimental | All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo |
|
| Placebo | Drug | Subcutaneous (SC) injection |
|
| Up to 246 days |
| Pharmacokinetics; Time to maximum serum concentration [Tmax] | Tmax of DONQ52 | Up to 246 days |
| Pharmacokinetics; Area under the serum concentration time curve [AUC] | AUC of DONQ52 | Up to 246 days |
| Pharmacokinetics; Half life [T1/2] | T1/2 of DONQ52 | Up to 246 days |
| Immunogenicity | Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52 | Up to 246 days |
| Denver |
| Colorado |
| 80209 |
| United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Clinical Site Partners | Leesburg | Florida | 34748 | United States |
| Clinical Site Partners - Orlando | Winter Park | Florida | 32789 | United States |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55095 | United States |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
| Lucas Research - Diabetes & Endocrinology Consultants, PC | Morehead City | North Carolina | 28557 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | United States |
| Digestive Specialists Inc | Dayton | Ohio | 45414 | United States |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | 29621 | United States |
| Alliance for Multispecialty Research | Knoxville | Tennessee | 37920 | United States |
| Digestive Research of Central Texas | Waco | Texas | 76712 | United States |
| Care Access Research | Ogden | Utah | 84403 | United States |
| Campbelltown Hospital | Campbelltown | New South Wales | 2560 | Australia |
| University of Sunshine Coast Clinical Trials Centre - Morayfield | Morayfield | Queensland | 4506 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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