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This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.
A total of 24 normal healthy adult participants will be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort. Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo on Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single IV Infusion |
|
| XTMAB-16 2mg/kg | Experimental | Single IV Infusion |
|
| XTMAB-16 4mg/kg | Experimental | Single IV Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single dose of 2 or 4 mg/kg |
| |
| XTMAB-16 2 mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| Participant With Treatment Emergent Adverse Events (TEAEs) | Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins. | Up to day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA) | Participants by cohort who test positive for XTMAB-16 ADA | ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71 |
| Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ray Goldwater, MDCM, M.Sc(A), CPI | Parexel Baltimore Early Phase Clinical Unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Harbor Hospital | Baltimore | Maryland | 21225 | United States |
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A total of 24 normal healthy adult participants were planned to be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo). Participants received a single IV infusion of 2 or 4 mg/kg of study drug (XTMAB-16 or placebo) on Day 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pooled Placebo | Participants received a single IV Infusion of Placebo |
| FG001 | Single IV Infusion of 2 mg/kg of XTMAB-16 | Participants received a single dose of 2 mg/kg of XTMAB-16 |
| FG002 | Single IV Infusion of 4 mg/kg of XTMAB-16 | Participants received a single dose of 4 mg/kg of XTMAB-16 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single IV Infusion of 2 mg/kg of XTMAB-16 | Participants received a single dose of 2 mg/kg XTMAB-16 |
| BG001 | Single IV Infusion of 4 mg/kg of XTMAB-16 | Participants received a single dose of 4 mg/kg XTMAB-16 |
| 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 | Participant With Treatment Emergent Adverse Events (TEAEs) | Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins. | Posted | Count of Participants | Participants | Up to day 71 |
|
The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
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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 | 2 mg/kg XTMAB-16 | Single IV Infusion of 2 mg/kg XTMAB-16 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Matthews, Director of Clinical Research | Xentria, Inc. | 224.443.4615 | tmatthews@xentria.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 | May 28, 2021 | Mar 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2022 | Mar 23, 2023 | SAP_001.pdf |
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| Drug |
Single dose of 2 mg/kg |
|
| XTMAB-16 4mg/kg | Drug | Single dose of 4 mg/kg |
|
Participants by cohort who test positive for XTMAB-16 nAb |
| ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71 |
| XTMAB-16 Maximum Observed Concentration (Cmax) | XTMAB-16 (Cmax) | Up to day 71 |
| XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1 | XTMAB-16 serum (CT) Day 1 | Day 1 |
| Time to Maximum Observed Concentration (Tmax) XTMAB-16 | Time to maximum observed concentration (tmax) XTMAB-16 | PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71 |
| Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) | Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞ | PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71 |
| Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) | Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t | PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71 |
| Systemic Clearance After IV Dosing (CL) | Systemic clearance after IV dosing (CL) | Up to day 71 |
| Apparent Terminal Half-life (t1/2) | Up to day 71 |
| Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71 | Up to day 71 |
| Mean Residence Time (MRT) | Mean residence time (MRT) | Up to day 71 |
| BG002 | Pooled Placebo | Participants received a single IV Infusion of Placebo |
| BG003 | 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 |
|
|
|
| Secondary | Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA) | Participants by cohort who test positive for XTMAB-16 ADA | Posted | Count of Participants | Participants | ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71 |
|
|
|
| Secondary | Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb) | Participants by cohort who test positive for XTMAB-16 nAb | Posted | Count of Participants | Participants | ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71 |
|
|
|
| Secondary | XTMAB-16 Maximum Observed Concentration (Cmax) | XTMAB-16 (Cmax) | Posted | Mean | Standard Deviation | Cmax (μg/mL) | Up to day 71 |
|
|
|
| Secondary | XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1 | XTMAB-16 serum (CT) Day 1 | Posted | Mean | Standard Deviation | CT (μg/mL) | Day 1 |
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) XTMAB-16 | Time to maximum observed concentration (tmax) XTMAB-16 | Posted | Median | Full Range | tmax (h) | PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71 |
|
|
|
| Secondary | Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) | Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞ | Posted | Mean | Standard Deviation | AUC0-inf (day*μg/mL) | PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71 |
|
|
|
| Secondary | Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) | Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t | Posted | Mean | Standard Deviation | AUC0-last (day*μg/mL) | PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71 |
|
|
|
| Secondary | Systemic Clearance After IV Dosing (CL) | Systemic clearance after IV dosing (CL) | Posted | Mean | Standard Deviation | CL (L/day) | Up to day 71 |
|
|
|
| Secondary | Apparent Terminal Half-life (t1/2) | Posted | Mean | Standard Deviation | t1/2 (day) | Up to day 71 |
|
|
|
| Secondary | Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71 | Posted | Mean | Standard Deviation | Vz (L) | Up to day 71 |
|
|
|
| Secondary | Mean Residence Time (MRT) | Mean residence time (MRT) | Posted | Mean | Standard Deviation | MRT (day) | Up to day 71 |
|
|
|
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | 4 mg/kg XTMAB-16 | Single IV Infusion of 4 mg/kg XTMAB-16 | 0 | 9 | 1 | 9 | 4 | 9 |
| EG002 | Pooled Placebo | Single IV Infusion of Placebo | 0 | 6 | 0 | 6 | 2 | 6 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment |
|
| Catheter Site Pain | General disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Eye Pain due to Covid Testing | Eye disorders | Systematic Assessment |
|
| Dry Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
|
| Foggy Feeling | General disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Day 15 ADA Screening |
|
| Day 15 ADA Confirmatory |
|
| Day 29 ADA Screening |
|
| Day 29 ADA Confirmatory |
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| Day 43 ADA Screening |
|
| Day 43 ADA Confirmatory |
|
| Day 57 ADA Screening |
|
| Day 57 ADA Confirmatory |
|
| Day 71 ADA Screening |
|
| Day 71 ADA Confirmatory |
|
| Title | Measurements |
|---|---|
|
| Day 57 |
|
| Day 71 |
|