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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000405-71 | EudraCT Number | ||
| 217692/Z/19/Z | Other Grant/Funding Number | Wellcome Trust Grant Number |
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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This was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of KAE609 given in the vein.
The study consisted of 2 parts: single-ascending dose (SAD) part and multiple ascending dose (MAD) part.
In Part A (Single-ascending dose (SAD) part), it was planned to recruit 6 active, 2 placebo subjects in each cohort:
In Part B (Multiple-ascending dose (MAD) part), Subjects were assigned to one of the following treatment arms in a ratio of 2:1 (6 active, 3 placebo):
Eligible subjects were randomized to receive a single or q24h x 5 doses of either KAE609 or placebo. Safety, tolerability and pharmacokinetics were assessed over the period of 8 days for single dose and 12 days for multiple dose up to end of study visit for each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: 10.5 mg/placebo | Experimental | Single iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Cohort A2: 30 mg/placebo | Experimental | Single iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Cohort A3: 75 mg/placebo | Experimental | Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Cohort A4: 120 mg/placebo | Experimental | Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Cohort A5: 210 mg/placebo | Experimental | Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAE609 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths | The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters. | From study treatment start date till 30 days safety follow-up, assessed for up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Antwerp | B-2060 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39058022 | Derived | Venishetty VK, Lecot J, Nguyen A, Zhang J, Prince WT. First-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending doses clinical study to assess the safety, tolerability, and pharmacokinetics of cipargamin administered intravenously in healthy adults. Antimicrob Agents Chemother. 2024 Sep 4;68(9):e0128723. doi: 10.1128/aac.01287-23. Epub 2024 Jul 26. |
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This study was conducted in one center in Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg) | Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel. |
| FG001 | Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg) | Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel. |
| FG002 | Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg) | Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel. |
| FG003 | Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg) | Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel. |
| FG004 | Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg) | Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel. |
| FG005 | Part A (Single-ascending Dose (SAD): Pooled Placebo | All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5) |
| FG006 | Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg) | Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. |
| FG007 | Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg) | Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. |
| FG008 | Part B (Multiple-ascending Dose (MAD): Pooled Placebo | All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg) | Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel. |
| BG001 | Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths | The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters. | Safety Analysis Set | Posted | Count of Participants | Participants | From study treatment start date till 30 days safety follow-up, assessed for up to 4 months |
|
On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg) | Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Testicular embryonal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal sensation in eye | Eye disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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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 | Oct 29, 2020 | Oct 27, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2021 | Oct 27, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C552304 | NITD 609 |
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| Cohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 days | Experimental | Multiple iv bolus doses of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Cohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days | Experimental | Multiple iv infusion doses of KAE609 or placebo administered at the clinical site by the study personnel. |
|
| Placebo | Drug | matching placeo for iv administration |
|
| Part A - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUCinf was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part A - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part A - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part A - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics. | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
| Part B - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel. |
| BG002 | Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg) | Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel. |
| BG003 | Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg) | Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel. |
| BG004 | Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg) | Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel. |
| BG005 | Part A (Single-ascending Dose (SAD): Pooled Placebo | All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5) |
| BG006 | Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg) | Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. |
| BG007 | Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg) | Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. |
| BG008 | Part B (Multiple-ascending Dose (MAD): Pooled Placebo | All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2) |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel. |
| OG002 | Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg) | Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel. |
| OG003 | Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg) | Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel. |
| OG004 | Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg) | Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel. |
| OG005 | Part A (Single-ascending Dose (SAD): Pooled KAE609 | All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5) |
| OG006 | Part A (Single-ascending Dose (SAD): Pooled Placebo | All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5) |
| OG007 | Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg) | Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. |
| OG008 | Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg) | Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. |
| OG009 | Part B (Multiple-ascending Dose (MAD): Pooled KAE609 | All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2) |
| OG010 | Part B (Multiple-ascending Dose (MAD): Pooled Placebo | All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2) |
|
|
| Secondary | Part A - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
|
|
| Secondary | Part A - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Median | Full Range | Hour (hr) | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
|
|
| Secondary | Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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|
| Secondary | Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUCinf was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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| Secondary | Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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| Secondary | Part A - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Hour (hr) | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
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| Secondary | Part A - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Milliliter/hour (mL/h) | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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| Secondary | Part A - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Milliliter (mL) | Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
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| Secondary | Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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| Secondary | Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Median | Full Range | Hour (hr) | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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| Secondary | Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
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| Secondary | Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
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| Secondary | Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Hour (hr) | Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
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| Secondary | Part B - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Milliliter/hour (mL/h) | Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
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| Secondary | Part B - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz) | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Milliliter (mL) | Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg) | Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg) | Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg) | Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel. | 0 | 6 | 1 | 6 | 2 | 6 |
| EG004 | Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg) | Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Part A (Single-ascending Dose (SAD): Pooled KAE609 | All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5) | 0 | 30 | 1 | 30 | 10 | 30 |
| EG006 | Part A (Single-ascending Dose (SAD): Pooled Placebo | All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5) | 0 | 9 | 0 | 9 | 5 | 9 |
| EG007 | Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg) | Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG008 | Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg) | Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG009 | Part B (Multiple-ascending Dose (MAD): Pooled KAE609 | All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2) | 0 | 12 | 0 | 12 | 10 | 12 |
| EG010 | Part B (Multiple-ascending Dose (MAD): Pooled Placebo | All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2) | 0 | 6 | 0 | 6 | 4 | 6 |
| Testicular malignant teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Catheter site oedema | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Infusion site discomfort | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Electrocardiogram T wave inversion | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
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| Semen discolouration | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D000079426 |
| Vector Borne Diseases |