Back to resultsAn Early Phase 2 Clinical Study of KSP-0243
Primary Purpose
Colitis, Ulcerative
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KSP-0243
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
Eligibility Criteria
Inclusion Criteria: Patients aged 18 to 74 years old (both inclusive) Patients who have been given the diagnosis of ulcerative colitis for at least 12 weeks Patients with an endoscopic view typically seen with ulcerative colitis spreading > 15 cm from the anal verge Patients with mild to moderate active ulcerative colitis who meet the certain conditions Patients who have an inadequate response to a fixed-dose oral 5-ASA formulation (mesalazine or salazosulfapyridine) continued from at least 2 weeks prior to the start of the screening period Exclusion Criteria: Patients who underwent an enterectomy or are expected to require an enterectomy during the study period (except appendectomy) Patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with Clostridium difficile) Patients with any of the following concomitant illnesses with the severity considered inappropriate as a study patient by the principal investigator or the subinvestigator or medical history thereof: Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases,
Sites / Locations
- Research SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KSP-0243
Placebo
Arm Description
Under double-blinding, KSP 0243 tablets will be orally administered.
Under double-blinding, placebo tablets will be orally administered.
Outcomes
Primary Outcome Measures
Clinical response rate based on the modified Mayo score at Week 8
The percentage of patients who satisfied both of the following requirements:
Decreases in the modified Mayo score by ≥ 30% and ≥ 2 points from baseline
The rectal bleeding subscore based on the Mayo score decreases by ≥ 1 point from baseline or the subscore becomes ≤ 1 point
Secondary Outcome Measures
Clinical remission rate based on the modified Mayo score at Week 8
Clinical remission rate based on the modified Mayo score: The percentage of patients who satisfied all of the following requirements:
The stool frequency subscore based on the Mayo score is 0 or 1 point with no aggravation from baseline
The rectal bleeding subscore based on the Mayo score is 0 points
The endoscopy subscore of the Mayo score is 0 or 1 point
Clinical response rate based on the full Mayo score at Week 8
Clinical response rate based on the full Mayo score: The percentage of patients who satisfied all of the following requirements.
Decreases in the full Mayo score by ≥ 30% and ≥ 3 points from baseline
The rectal bleeding subscore based on the Mayo score decreases by ≥ 1 point from baseline or the subscore becomes ≤ 1 point
Clinical remission rate based on the full Mayo score at Week 8
Clinical remission rate based on the full Mayo score: The percentage of patients who satisfied all of the following requirements.
Full Mayo score is ≤ 2 points
All the subscores are ≤ 1 point
Incidence of adverse events (AE) and adverse drug reactions (ADR)
- Adverse events, Adverse drug reactions
Laboratory tests (Hematology): Hemoglobin (g/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory tests (Hematology): Hematocrit (%)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory tests (Hematology): Erythrocyte (10^10/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Leukocyte (10^6/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Neutrophil (10^8/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Eosinophil (10^8/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Basophil (10^8/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Monocyte (10^8/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Lymphocyte (10^8/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Hematology): Platelet (10^10/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Na (mEq/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): K (mEq/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Cl (mEq/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Ca (mEq/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): P (mEq/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Creatinine (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Total Bilirubin (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Total Protein (g/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Albumin (g/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): AST (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): ALT (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): γGTP (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): ALP (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Creatinine kinase (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Uric acid (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): BUN (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): LDH (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Total Cholesterol (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Triglyceride (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Amylase (U/L)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Blood chemistry): Glucose (mg/dL)
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Laboratory test (Urinalysis): Protein
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Laboratory test (Urinalysis): Glucose
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Laboratory test (Urinalysis): Urobilinogen
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Laboratory test (Urinalysis): Occult blood
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Vital signs: Systolic blood pressure (mmHg)
- Summary statistics, scattered plots before and after the dose will be presented.
Vital signs: Diastolic blood pressure (mmHg)
- Summary statistics, scattered plots before and after the dose will be presented.
Vital signs: Pulse rate (bpm)
- Summary statistics, scattered plots before and after the dose will be presented.
Vital signs: Body temperature (°C)
- Summary statistics, scattered plots before and after the dose will be presented.
Measured values and fluctuations in body weight
- Body weight
ECG parameter: RR interval (msec)
- Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: PR interval (msec)
- Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: QRS interval (msec)
- Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: QT interval (msec)
- Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: QTcF interval (msec)
- Summary statistics will be presented for measured values and changes from baseline.
ECG parameter: Pulse rate (bpm)
- Summary statistics will be presented for measured values and changes from baseline.
KSP-0243 concentration in plasma at each time point
- KSP-0243 concentration in plasma
KSP-0243 concentration in colorectal mucosa at Week 8
- KSP-0243 concentration in colorectal mucosa
Full Information
NCT ID
NCT05831670
First Posted
March 2, 2023
Last Updated
May 24, 2023
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05831670
Brief Title
An Early Phase 2 Clinical Study of KSP-0243
Official Title
An Early Phase 2 Clinical Study of KSP-0243 in Patients With Mild to Moderate Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study to administer KSP-0243 or a placebo once daily after breakfast for 8 weeks in 100 patients with mild to moderate active ulcerative colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KSP-0243
Arm Type
Experimental
Arm Description
Under double-blinding, KSP 0243 tablets will be orally administered.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Under double-blinding, placebo tablets will be orally administered.
Intervention Type
Drug
Intervention Name(s)
KSP-0243
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Clinical response rate based on the modified Mayo score at Week 8
Description
The percentage of patients who satisfied both of the following requirements:
Decreases in the modified Mayo score by ≥ 30% and ≥ 2 points from baseline
The rectal bleeding subscore based on the Mayo score decreases by ≥ 1 point from baseline or the subscore becomes ≤ 1 point
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Clinical remission rate based on the modified Mayo score at Week 8
Description
Clinical remission rate based on the modified Mayo score: The percentage of patients who satisfied all of the following requirements:
The stool frequency subscore based on the Mayo score is 0 or 1 point with no aggravation from baseline
The rectal bleeding subscore based on the Mayo score is 0 points
The endoscopy subscore of the Mayo score is 0 or 1 point
Time Frame
Up to 8 weeks
Title
Clinical response rate based on the full Mayo score at Week 8
Description
Clinical response rate based on the full Mayo score: The percentage of patients who satisfied all of the following requirements.
Decreases in the full Mayo score by ≥ 30% and ≥ 3 points from baseline
The rectal bleeding subscore based on the Mayo score decreases by ≥ 1 point from baseline or the subscore becomes ≤ 1 point
Time Frame
Up to 8 weeks
Title
Clinical remission rate based on the full Mayo score at Week 8
Description
Clinical remission rate based on the full Mayo score: The percentage of patients who satisfied all of the following requirements.
Full Mayo score is ≤ 2 points
All the subscores are ≤ 1 point
Time Frame
Up to 8 weeks
Title
Incidence of adverse events (AE) and adverse drug reactions (ADR)
Description
- Adverse events, Adverse drug reactions
Time Frame
Up to 8 weeks
Title
Laboratory tests (Hematology): Hemoglobin (g/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory tests (Hematology): Hematocrit (%)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory tests (Hematology): Erythrocyte (10^10/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Leukocyte (10^6/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Neutrophil (10^8/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Eosinophil (10^8/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Basophil (10^8/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Monocyte (10^8/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Lymphocyte (10^8/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Hematology): Platelet (10^10/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Na (mEq/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): K (mEq/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Cl (mEq/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Ca (mEq/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): P (mEq/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Creatinine (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Total Bilirubin (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Direct Bilirubin (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Indirect Bilirubin (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Total Protein (g/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Albumin (g/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): AST (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): ALT (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): γGTP (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): ALP (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Creatinine kinase (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Uric acid (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): BUN (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): LDH (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Total Cholesterol (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Triglyceride (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Amylase (U/L)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Blood chemistry): Glucose (mg/dL)
Description
Summary statistics, scattered plots before and after the dose will be presented.
Shift tables before and after dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Urinalysis): Protein
Description
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Urinalysis): Glucose
Description
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Urinalysis): Urobilinogen
Description
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Laboratory test (Urinalysis): Occult blood
Description
Number and percentage of subjects will be presented.
Shift tables before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Vital signs: Systolic blood pressure (mmHg)
Description
- Summary statistics, scattered plots before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Vital signs: Diastolic blood pressure (mmHg)
Description
- Summary statistics, scattered plots before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Vital signs: Pulse rate (bpm)
Description
- Summary statistics, scattered plots before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Vital signs: Body temperature (°C)
Description
- Summary statistics, scattered plots before and after the dose will be presented.
Time Frame
Up to 8 weeks
Title
Measured values and fluctuations in body weight
Description
- Body weight
Time Frame
Up to 8 weeks
Title
ECG parameter: RR interval (msec)
Description
- Summary statistics will be presented for measured values and changes from baseline.
Time Frame
Up to 8 weeks
Title
ECG parameter: PR interval (msec)
Description
- Summary statistics will be presented for measured values and changes from baseline.
Time Frame
Up to 8 weeks
Title
ECG parameter: QRS interval (msec)
Description
- Summary statistics will be presented for measured values and changes from baseline.
Time Frame
Up to 8 weeks
Title
ECG parameter: QT interval (msec)
Description
- Summary statistics will be presented for measured values and changes from baseline.
Time Frame
Up to 8 weeks
Title
ECG parameter: QTcF interval (msec)
Description
- Summary statistics will be presented for measured values and changes from baseline.
Time Frame
Up to 8 weeks
Title
ECG parameter: Pulse rate (bpm)
Description
- Summary statistics will be presented for measured values and changes from baseline.
Time Frame
Up to 8 weeks
Title
KSP-0243 concentration in plasma at each time point
Description
- KSP-0243 concentration in plasma
Time Frame
Up to 8 weeks
Title
KSP-0243 concentration in colorectal mucosa at Week 8
Description
- KSP-0243 concentration in colorectal mucosa
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 74 years old (both inclusive)
Patients who have been given the diagnosis of ulcerative colitis for at least 12 weeks
Patients with an endoscopic view typically seen with ulcerative colitis spreading > 15 cm from the anal verge
Patients with mild to moderate active ulcerative colitis who meet the certain conditions
Patients who have an inadequate response to a fixed-dose oral 5-ASA formulation (mesalazine or salazosulfapyridine) continued from at least 2 weeks prior to the start of the screening period
Exclusion Criteria:
Patients who underwent an enterectomy or are expected to require an enterectomy during the study period (except appendectomy)
Patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with Clostridium difficile)
Patients with any of the following concomitant illnesses with the severity considered inappropriate as a study patient by the principal investigator or the subinvestigator or medical history thereof:
Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshitaka Shimizu
Phone
E-mail only
Email
rinsyousiken@pharm.kissei.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshitaka Shimizu
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Multiple Locations
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Early Phase 2 Clinical Study of KSP-0243
We'll reach out to this number within 24 hrs