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Trial record 2 of 3 for:    CBP-307

A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04818229
Recruitment Status : Active, not recruiting
First Posted : March 26, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Connect Biopharmaceuticals, Ltd.

Tracking Information
First Submitted Date  ICMJE March 24, 2021
First Posted Date  ICMJE March 26, 2021
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
Change-from-baseline QT interval corrected for heart rate using Fridericia's method (QTcF) [ Time Frame: From Baseline to Day 16 ]
Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2021)
  • Change-from-baseline heart rate (HR) [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in heart rate (HR).
  • Change-from-baseline PR [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in PR.
  • Change-from-baseline QRS [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in QRS.
  • Placebo-corrected change-from-baseline HR [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in HR with Placebo correction.
  • Placebo-corrected change-from-baseline QTcF [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in QTcF with Placebo correction.
  • Placebo-corrected change-from-baseline PR [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in PR with Placebo correction.
  • Placebo-corrected change-from-baseline QRS [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in QRS with Placebo correction.
  • Categorical outliers for QTcF [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, the number (percentage) of subjects as well as timepoints who had increases in absolute QTcF values >450 and ≤480 msec, >480 and ≤500 msec, or >500 msec, and changes from predose baseline of >30 and ≤60 msec, or >60 msec.
  • Categorical outliers for HR [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, decrease in HR from predose baseline >25% to an HR <50 bpm will be determined.
  • Categorical outliers for PR [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, increase in PR from predose baseline >25% to a PR > 200 msec will be determined.
  • Categorical outliers for QRS [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, increase in QRS from predose baseline >25% to a QRS >120 msec will be determined.
  • Frequency of treatment-emergent changes of T-wave morphology [ Time Frame: From Baseline to Day 16 ]
    For T-wave morphology, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
  • Frequency of treatment-emergent changes of U-wave presence [ Time Frame: From Baseline to Day 16 ]
    For U-wave presence, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
  • Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) [ Time Frame: From Baseline to Day 29 ± 2 ]
    Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter.
  • Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) [ Time Frame: From Baseline to Day 29 ± 2 ]
    Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter.
  • Maximum observed concentration (Cmax) [ Time Frame: From Baseline to Day 29 ± 2 ]
    Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter.
  • Time of the maximum observed concentration (tmax) [ Time Frame: From Baseline to Day 29 ± 2 ]
    Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter.
  • Incidence and severity of Adverse Event (AE) [ Time Frame: From Baseline to Day 29 ± 2 ]
    All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Change-from-baseline heart rate (HR) [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in heart rate (HR).
  • Change-from-baseline PR [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in PR.
  • Change-from-baseline QRS [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in QRS.
  • Placebo-corrected change-from-baseline HR [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in HR with Placebo correction.
  • Placebo-corrected change-from-baseline QTcF [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in QTcF with Placebo correction.
  • Placebo-corrected change-from-baseline PR [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in PR with Placebo correction.
  • Placebo-corrected change-from-baseline QRS [ Time Frame: From Baseline to Day 16 ]
    Change from Baseline in QRS with Placebo correction.
  • Categorical outliers for QTcF [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, the number (percentage) of subjects as well as timepoints who had increases in absolute QTcF values >450 and ≤480 msec, >480 and ≤500 msec, or >500 msec, and changes from predose baseline of >30 and ≤60 msec, or >60 msec.
  • Categorical outliers for HR [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, decrease in HR from predose baseline >25% to an HR <50 bpm will be determined.
  • Categorical outliers for PR [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, increase in PR from predose baseline >25% to a PR > 200 msec will be determined.
  • Categorical outliers for QRS [ Time Frame: From Baseline to Day 16 ]
    For categorical outliers, increase in QRS from predose baseline >25% to a QRS >120 msec will be determined.
  • Frequency of treatment-emergent changes of T-wave morphology [ Time Frame: From Baseline to Day 16 ]
    For T-wave morphology, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
  • Frequency of treatment-emergent changes of U-wave presence [ Time Frame: From Baseline to Day 16 ]
    For U-wave presence, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
  • Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) [ Time Frame: From Baseline to Day 28 ± 2 ]
    Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter.
  • Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) [ Time Frame: From Baseline to Day 28 ± 2 ]
    Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter.
  • Maximum observed concentration (Cmax) [ Time Frame: From Baseline to Day 28 ± 2 ]
    Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter.
  • Time of the maximum observed concentration (tmax) [ Time Frame: From Baseline to Day 28 ± 2 ]
    Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter.
  • Incidence and severity of Adverse Event (AE) [ Time Frame: From Baseline to Day 28 ± 2 ]
    All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
Official Title  ICMJE A Phase I, Single-center, Randomized, Double-blind, Double-dummy, Placebo- and Positive-Controlled Study to Investigate the Effects of CBP-307 on the QTc Interval in Healthy Subjects
Brief Summary This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
Detailed Description This will be a Phase I, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, single-site study to investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy male and female subjects. The study is divided into a treatment period of 21 days and a follow-up period of 10 ± 2 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Autoimmune Diseases
Intervention  ICMJE
  • Drug: CBP-307
    CBP-307 capsules oral administration.
  • Drug: Placebo-matched CBP-307
    Placebo-matched CBP-307 capsules oral administration.
  • Drug: Moxifloxacin (Avelox)
    Moxifloxacin tablets oral administration。
  • Drug: Placebo-matched Moxifloxacin
    Placebo-matched Moxifloxacin tablets oral administration.
Study Arms  ICMJE
  • Experimental: Investigational Group 1
    Therapeutic and supratherapeutic multiple oral doses of CBP-307.
    Interventions:
    • Drug: CBP-307
    • Drug: Placebo-matched CBP-307
    • Drug: Placebo-matched Moxifloxacin
  • Placebo Comparator: Investigational Group 2
    Moxifloxacin (positive control for method validation) and Placebo oral administration.
    Interventions:
    • Drug: Placebo-matched CBP-307
    • Drug: Moxifloxacin (Avelox)
    • Drug: Placebo-matched Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or females, of any race, between 18 and 60 years of age, inclusive.
  2. Body mass index between 18.0 and 30.0 kg/mE2, inclusive.
  3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and confirmed at check-in as assessed by the investigator (or designee).
  4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. Negative pregnancy test for females of childbearing potential at screening (blood test) and check-in (urine test).
  5. Supine diastolic blood pressure between 60 and 90 mmHg and systolic blood pressure between 90 and 140 mmHg (inclusive) at screening on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
  6. No clinically significant history or presence of ECG findings as judged by the investigator at screening and check-in, including each criterion as listed below:

    1. Normal sinus rhythm (HR between 60 bpm and 100 bpm inclusive);
    2. QTcF interval ≤450 msec for males and ≤470 msec for females;
    3. QRS interval ≤110 msec; and confirmed by manual over-read if >110 msec;
    4. PR interval ≤200 msec.
  7. Has serum potassium, calcium, and magnesium levels within the normal reference range at screening, as judged by the investigator.
  8. Able to swallow multiple tablets (based on subject's verbal confirmation).
  9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

-

Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit unless otherwise stated:

  1. Subject is mentally or legally incapacitated or has had significant history of recent mental health issues requiring medication and/or hospitalization at the time of the screening visit or expected during the conduct of the study.
  2. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). Note: Childhood asthma that is considered recovered or seasonal allergies that are not currently active or requiring treatment are allowed.
  3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
  4. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, or inactive ingredients.
  5. History of significant multiple and/or severe allergies (eg, latex allergy, band-aids, adhesive dressing, or medical tape), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs.
  6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs within 6 months prior to the first dose of study drug (uncomplicated appendectomy and hernia repair will be allowed).
  7. History or presence of:

    1. Hypokalemia, in the opinion of the investigator (or designee);
    2. Risk factors for Torsades de Pointes (eg, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
    3. Sick sinus syndrome, second, or third degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities;
    4. Repeated or frequent syncope or vasovagal episodes;
    5. Hypertension, angina, bradycardia, or severe peripheral arterial circulatory disorders.
  8. Clinically significant abnormalities (as judged by the investigator in laboratory tests results [out-of-range results confirmed on repeat]), including but not limited to the following parameters:

    1. alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than 1.5 × upper limit of normal;
    2. hemoglobin <10 g/dL, WBC <3.0 ×10E9/L, neutrophils <1.5 ×10E9/L, lymphocytes <0.8 ×10E9/L and platelets <100 ×10E9/L or >1200 × 10E9/L;
  9. History or evidence of alcoholism or drug/chemical abuse within 2 years prior to check-in.
  10. Alcohol consumption of >10 units per week for males and females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
  11. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
  12. Positive hepatitis panel, positive syphilis test, and/or positive human immunodeficiency virus test.
  13. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 28 days prior to the first dose of study treatment on Day 1. The 28-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
  14. Participation in a previous clinical study where subjects received CBP-307.
  15. Administration of a Coronavirus Disease 2019 (COVID-19) vaccine in the past 28 days prior to first dose of study treatment on Day 1.
  16. Use or intend to use any prescription medications/products within 14 days prior to first dose of study drug (Day 1) and throughout the study, unless deemed acceptable by the investigator (or designee). Note: For females only, the use hormonal contraception, hormone replacement therapy or oral, implantable, transdermal, injectable, or intrauterine hormonal contraceptives within 14 days prior to Day 1 is not acceptable, except for Mirena®.
  17. Use or intend to use any drugs known to be significant inhibitors or inducers of CYP enzymes and/or P-gp, including St. John's Wort, for days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the investigator or designee to confirm the lack of PK/PD interaction with the study drug.
  18. Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
  19. Use or intend to use any nonprescription medications/products including antacids, vitamins (especially those containing magnesium, aluminum, iron, or zinc), minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
  20. Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
  21. Has been on a diet incompatible with the on-study diet (including an extreme diet which resulted in a significant weight change for whatever reason), in the opinion of the investigator, within the 28 days prior to the first dose of study treatment, and throughout the study.
  22. Consumption of caffeine/xanthine-containing foods or beverages within 48 hours prior to check-in until discharge.
  23. Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
  24. Receipt of blood products within 2 months prior to check-in.
  25. Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
  26. Poor peripheral venous access.
  27. Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04818229
Other Study ID Numbers  ICMJE CBP-307AU002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suzhou Connect Biopharmaceuticals, Ltd.
Study Sponsor  ICMJE Suzhou Connect Biopharmaceuticals, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Suzhou Connect Suzhou Connect Biopharmaceuticals, Ltd.
PRS Account Suzhou Connect Biopharmaceuticals, Ltd.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP