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| ID | Type | Description | Link |
|---|---|---|---|
| U01DA053054 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
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| Cohort 2 | Experimental | 6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
|
| Cohort 3 | Experimental | 6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
|
| Cohort 4 | Experimental | 6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
|
| Placebo | Placebo Comparator | 2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-1103 | Drug | CS-1103 for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis). | 3 days plus 8 days for follow-up |
| Number of Participants by Severity of AEs | Severity of AEs was classified as mild, moderate, or severe (increasing severity). A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment. | 3 days plus 8 days for follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetic (PK) Parameter: Cmax | Maximum concentration, obtained directly from the observed concentration versus time data. | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
| Plasma PK Parameter: Tmax |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Vince Clinical Research | Overland Park | Kansas | 66212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (2.5 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| FG001 | Cohort 2 (7.5 mg/kg CS-1103 [Free Acid]) | 6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| FG002 | Cohort 3 (15.1 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| FG003 | Cohort 4 (17.9 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| FG004 | Placebo | 2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (2.5 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| BG001 | Cohort 2 (7.5 mg/kg CS-1103 [Free Acid]) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Treatment-Emergent Adverse Events (AEs) | Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis). | Posted | Count of Participants | Participants | 3 days plus 8 days for follow-up |
|
3 days plus 8 days for follow-up
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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 | Cohort 1 (2.5 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Piercen Oliver | Clear Scientific | 617-621-8500 | poliver@clearsci.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 3, 2023 | Sep 17, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2024 | Sep 17, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2024 | Aug 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
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| Sterile Saline | Drug | Sterile Saline for Injection |
|
Time of maximum observed blood plasma concentration (Cmax) of CS-1103 |
| End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
| Plasma PK Parameter: t1/2 | Terminal Elimination Half-life of CS-1103 | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
| Plasma PK Parameter: CL | Systemic Clearance of CS-1103 | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
| Plasma PK Parameter: Vz | Volume of Distribution of CS-1103 | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
| Urine PK Parameter: Fe (0-last) | Cumulative fraction of dose excreted in urine during the pooled collection intervals. Due to inherent error in measuring CS-1103 recovered in urine, the calculated recovery may exceed 100% of the dose. | Time intervals from 0-24 hours after IV administration of CS-1103 |
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| BG002 | Cohort 3 (15.1 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| BG003 | Cohort 4 (17.9 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| BG004 | Placebo | 2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. |
| BG005 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
|
| OG001 |
| Cohort 2 (7.5 mg/kg CS-1103 [Free Acid]) |
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| OG002 | Cohort 3 (15.1 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| OG003 | Cohort 4 (17.9 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| OG004 | Placebo | 2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. |
|
|
| Primary | Number of Participants by Severity of AEs | Severity of AEs was classified as mild, moderate, or severe (increasing severity). A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment. | Posted | Count of Participants | Participants | 3 days plus 8 days for follow-up |
|
|
|
| Secondary | Plasma Pharmacokinetic (PK) Parameter: Cmax | Maximum concentration, obtained directly from the observed concentration versus time data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
|
|
|
| Secondary | Plasma PK Parameter: Tmax | Time of maximum observed blood plasma concentration (Cmax) of CS-1103 | Posted | Median | Full Range | hours | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
|
|
|
| Secondary | Plasma PK Parameter: t1/2 | Terminal Elimination Half-life of CS-1103 | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
|
|
|
| Secondary | Plasma PK Parameter: CL | Systemic Clearance of CS-1103 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
|
|
|
| Secondary | Plasma PK Parameter: Vz | Volume of Distribution of CS-1103 | Posted | Geometric Mean | Geometric Coefficient of Variation | L | End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr |
|
|
|
| Secondary | Urine PK Parameter: Fe (0-last) | Cumulative fraction of dose excreted in urine during the pooled collection intervals. Due to inherent error in measuring CS-1103 recovered in urine, the calculated recovery may exceed 100% of the dose. | Posted | Mean | Standard Deviation | percentage of dose administered | Time intervals from 0-24 hours after IV administration of CS-1103 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cohort 2 (7.5 mg/kg CS-1103 [Free Acid]) | 6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Cohort 3 (15.1 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | Cohort 4 (17.9 mg/kg CS-1103 [Free Acid]) | 6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | Placebo | 2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. | 0 | 8 | 0 | 8 | 0 | 8 |
| Tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
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| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Blood creatinine increased | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Glomerular filtration rate decreased | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
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| Moderate |
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| Severe |
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