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This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
This will be a Phase I, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, multi-site, 3-arm study to investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Group 1 | Experimental | Therapeutic and supratherapeutic multiple oral doses of CBP-307. |
|
| Investigational Group 2A | Placebo Comparator | Moxifloxacin (positive control for method validation) and Placebo oral administration. |
|
| Investigational Group 2B | Placebo Comparator | Moxifloxacin (positive control for method validation) and Placebo oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBP-307 | Drug | CBP-307 capsules oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) | 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. | From Baseline to Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change-from-baseline Heart Rate (HR) | Change from Baseline in heart rate (HR). | From Baseline at Day 16 |
| Change-from-baseline PR | Change from Baseline in PR. |
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Inclusion Criteria:
Males or females, of any race, between 18 and 60 years of age, inclusive.
Body mass index between 18.0 and 30.0 kg/mE2, inclusive.
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).
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).
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.
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:
Has serum potassium, calcium, and magnesium levels within the normal reference range at screening, as judged by the investigator.
Able to swallow multiple tablets (based on subject's verbal confirmation).
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:
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.
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.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, or inactive ingredients.
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.
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).
History or presence of:
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:
History or evidence of alcoholism or drug/chemical abuse within 2 years prior to check-in.
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.
Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
Positive hepatitis panel, positive syphilis test, and/or positive human immunodeficiency virus test.
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.
Participation in a previous clinical study where subjects received CBP-307.
Administration of a Coronavirus Disease 2019 (COVID-19) vaccine in the past 28 days prior to first dose of study treatment on Day 1.
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®.
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.
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).
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).
Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
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.
Consumption of caffeine/xanthine-containing foods or beverages within 48 hours prior to check-in until discharge.
Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
Receipt of blood products within 2 months prior to check-in.
Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
Poor peripheral venous access.
Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Australia Connect | Connect Biopharma Australia Pty Ltd | Study Director |
| Suzhou Connect | Connect Biopharm LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami (CPMI), LLC | Hialeah | Florida | 33014 | United States | ||
| CMAX |
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Placebo was administered to all subjects on Day -1, and assigned study treatments were administered on Days 1 through 16.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Group 1 | In Group 1, subjects received a starting dose of 0.05 mg CBP-307 on Day 1 followed by an up-titrated dose of 0.1 mg on Day 2 and a dose of 0.2 mg on Days 3 to 6 in order to achieve a therapeutic dose on Day 6. Dose administration continued with a dose of 0.5 mg CBP-307 on Days 7 to 15 in order to achieve a supratherapeutic dose on Day 15. CBP-307 and moxifloxacin placebo were administered on Day 16. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2022 | May 22, 2023 |
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| Placebo-matched CBP-307 |
| Drug |
Placebo-matched CBP-307 capsules oral administration. |
|
| Moxifloxacin (Avelox) | Drug | Moxifloxacin tablets oral administration。 |
|
| Placebo-matched Moxifloxacin | Drug | Placebo-matched Moxifloxacin tablets oral administration. |
|
| From Baseline at Day 16 |
| Change-from-baseline QRS | Change from Baseline in QRS. | From Baseline at Day 16 |
| Placebo-corrected Change-from-baseline HR | Placebo-corrected Change-from-baseline HR based on Change-from-baseline Heart Rate (HR) reported in Outcome Measure 2 | From Baseline to Day 16 |
| Placebo-corrected Change-from-baseline QTcF | Placebo-corrected change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) based on Change-from-baseline QTcF reported in Outcome Measure 1 | From Baseline to Day 16 |
| Placebo-corrected Change-from-baseline PR | Placebo-corrected change-from-baseline PR based on Change-from-baseline PR reported in Outcome Measure 3 | From Baseline to Day 16 |
| Placebo-corrected Change-from-baseline QRS | Placebo-corrected change-from-baseline QRS based on Change-from-baseline QRS reported in Outcome Measure 4 | From Baseline to Day 16 |
| Categorical Outliers for QTcF | 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. | From Baseline to Day 16 |
| Categorical Outliers for HR | For categorical outliers, decrease in HR from predose baseline >25% to an HR <50 bpm will be determined. | From Baseline to Day 16 |
| Categorical Outliers for PR | For categorical outliers, increase in PR from predose baseline >25% to a PR > 200 msec will be determined. | From Baseline to Day 16 |
| Categorical Outliers for QRS | For categorical outliers, increase in QRS from predose baseline >25% to a QRS >120 msec will be determined. | From Baseline to Day 16 |
| Frequency of Treatment-emergent Changes of T-wave Morphology | 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. | From Baseline to Day 16 |
| Frequency of Treatment-emergent Changes of U-wave Presence | 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. | From Baseline to Day 16 |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) | Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter. | From Baseline to Day 29 ± 2 |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) | Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter. | From Baseline to Day 29 ± 2 |
| Maximum Observed Concentration (Cmax) | Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter. | From Baseline to Day 29 ± 2 |
| Time of the Maximum Observed Concentration (Tmax) | Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter. | From Baseline to Day 29 ± 2 |
| Incidence and Severity of Adverse Event (AE) | All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology. 14.3.1.1 TEAE | From Baseline to Day 29 ± 2 |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| FG001 | Investigational Group 2A | In Group 2A, 400 mg moxifloxacin was administered on Day 1, with CBP-307 or moxifloxacin placebo administered on all other days. |
| FG002 | Investigational Group 2B | In Group 2B, 400 mg moxifloxacin was administered on Day 16, with CBP-307 or moxifloxacin placebo administered on all other days. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Group 1 | Therapeutic and supratherapeutic multiple oral doses of CBP-307. CBP-307: CBP-307 capsules oral administration. Placebo-matched CBP-307: Placebo-matched CBP-307 capsules oral administration. |
| BG001 | Investigational Group 2A | Moxifloxacin (positive control for method validation) and Placebo oral administration. Moxifloxacin (Avelox): Moxifloxacin tablets oral administration。 Placebo-matched Moxifloxacin: Placebo-matched Moxifloxacin tablets oral administration. |
| BG002 | Investigational Group 2B | Moxifloxacin (positive control for method validation) and Placebo oral administration. Moxifloxacin (Avelox): Moxifloxacin tablets oral administration。 Placebo-matched Moxifloxacin: Placebo-matched Moxifloxacin tablets oral administration. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Weight | Mean | Standard Deviation | Kg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) | 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. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | msec | From Baseline to Day 16 |
|
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| Secondary | Change-from-baseline Heart Rate (HR) | Change from Baseline in heart rate (HR). | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | beats/min | From Baseline at Day 16 |
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| Secondary | Change-from-baseline PR | Change from Baseline in PR. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | msec | From Baseline at Day 16 |
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| Secondary | Change-from-baseline QRS | Change from Baseline in QRS. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | msec | From Baseline at Day 16 |
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| Secondary | Placebo-corrected Change-from-baseline HR | Placebo-corrected Change-from-baseline HR based on Change-from-baseline Heart Rate (HR) reported in Outcome Measure 2 | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | beats/min | From Baseline to Day 16 |
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| Secondary | Placebo-corrected Change-from-baseline QTcF | Placebo-corrected change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) based on Change-from-baseline QTcF reported in Outcome Measure 1 | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | msec | From Baseline to Day 16 |
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| Secondary | Placebo-corrected Change-from-baseline PR | Placebo-corrected change-from-baseline PR based on Change-from-baseline PR reported in Outcome Measure 3 | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | msec | From Baseline to Day 16 |
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| Secondary | Placebo-corrected Change-from-baseline QRS | Placebo-corrected change-from-baseline QRS based on Change-from-baseline QRS reported in Outcome Measure 4 | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Least Squares Mean | Standard Error | msec | From Baseline to Day 16 |
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| Secondary | Categorical Outliers for QTcF | 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. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Count of Participants | Participants | From Baseline to Day 16 |
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| Secondary | Categorical Outliers for HR | For categorical outliers, decrease in HR from predose baseline >25% to an HR <50 bpm will be determined. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Count of Participants | Participants | From Baseline to Day 16 |
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| Secondary | Categorical Outliers for PR | For categorical outliers, increase in PR from predose baseline >25% to a PR > 200 msec will be determined. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Count of Participants | Participants | From Baseline to Day 16 |
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| Secondary | Categorical Outliers for QRS | For categorical outliers, increase in QRS from predose baseline >25% to a QRS >120 msec will be determined. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Count of Participants | Participants | From Baseline to Day 16 |
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| Secondary | Frequency of Treatment-emergent Changes of T-wave Morphology | 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. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Count of Participants | Participants | From Baseline to Day 16 |
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| Secondary | Frequency of Treatment-emergent Changes of U-wave Presence | 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. | Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B). | Posted | Count of Participants | Participants | From Baseline to Day 16 |
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| Secondary | Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) | Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter. | Only subjects in Group 1 received CBP-307. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | From Baseline to Day 29 ± 2 |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) | Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter. | Only subjects in Group 1 received CBP-307. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | From Baseline to Day 29 ± 2 |
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| Secondary | Maximum Observed Concentration (Cmax) | Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter. | Only subjects in Group 1 received CBP-307. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | From Baseline to Day 29 ± 2 |
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| Secondary | Time of the Maximum Observed Concentration (Tmax) | Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter. | Only subjects in Group 1 received CBP-307. | Posted | Median | Full Range | h | From Baseline to Day 29 ± 2 |
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| Secondary | Incidence and Severity of Adverse Event (AE) | All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology. 14.3.1.1 TEAE | Only subjects in Group 1 received CBP-307. | Posted | Number | participants | From Baseline to Day 29 ± 2 |
|
|
Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.05 mg CBP-307 | 0.05 mg CBP-307 on Day 1 | 0 | 55 | 0 | 55 | 4 | 55 |
| EG001 | 0.1 mg CBP-307 | 0.1 mg on Day 2 | 0 | 55 | 0 | 55 | 7 | 55 |
| EG002 | 0.2 mg CBP-307 | 0.2 mg on Days 3 to 6 | 0 | 55 | 0 | 55 | 14 | 55 |
| EG003 | 0.5 mg CBP-307 | 0.5 mg CBP-307 on Days 7 to 15 | 0 | 50 | 0 | 50 | 12 | 50 |
| EG004 | Investigational Group 1 | Therapeutic and supratherapeutic multiple oral doses of CBP-307. CBP-307: CBP-307 capsules oral administration. Placebo-matched CBP-307: Placebo-matched CBP-307 capsules oral administration. | 0 | 55 | 0 | 55 | 22 | 55 |
| EG005 | Investigational Group 2A+2B | Moxifloxacin (positive control for method validation) and Placebo oral administration. Moxifloxacin (Avelox): Moxifloxacin tablets oral administration。 Placebo-matched Moxifloxacin: Placebo-matched Moxifloxacin tablets oral administration. | 0 | 57 | 0 | 57 | 22 | 57 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site bruise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site dermatitis | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site irritation | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site irritation | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Application site vesicles | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Electrocardiogram PR prolongation | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear discomfort | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chin Lee, MD Chief Medial Officer | Connect Biopharma | +1 650 676 9617 | clee@connectpharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2022 | May 22, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
|
|
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories |
|---|
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Overall |
| |||||
| Serious |
| |||||
| Leading to Discontinuation |
| |||||
| Leading to Death |
|