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This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.
This is a Phase 1 clinical trial consisting of a dose-escalation and dose-expansion study to evaluate the safety, clinical tolerability, and pharmacokinetics of the intravenous liposomal dispersion product in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRIS115 treatment | Experimental | Injectable liposomal dispersion with a concentration of 22.08 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposome dispersion | Drug | liposome rescue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Treatment Related Adverse Events | The severity/intensity (grade 1 to grade 5) of adverse events will be assessed by the investigator as "unlikely," "possibly," or "probably" related to the investigational drug. An adverse event will be considered causally related to the use of the investigational drug when the causality assessment was "probable" or "possible." | From enrollment to the end of treatment at 2 weeks. |
| Safety: Number of Clinically Significant (CS) Changes in Physical Examination. | A complete physical examination includes assessments of selected body systems, at the investigator's discretion, but covers at least the cardiovascular, pulmonary, and neurological systems. Examination results will be documented in the eCRF as normal, abnormal without clinical significance (CNS), or abnormal with clinical significance (CS). Post-dose physical examination findings classified as abnormal CS will be reported as adverse events (AEs). | From enrollment to the end of treatment at 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The Maximal Plasma Concentration (Cmax) after a single dose of liposome in fasting conditions. | From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Hamamoto | Contact | 55 19 3795-1100 | daniele.hamamoto@cristalia.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniele Hamamoto | Campinas | São Paulo | Brazil |
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The innovative investigational drug is a liposomal dispersion that functions as an effective detoxifying agent by sequestering circulating intoxicants and removing excess levels from the bloodstream. This mechanism supports the reversal of clinical signs of overdose and the prevention of tissue damage. Given its novel nature, the proposed study aims to evaluate the safety and tolerability of the product in healthy participants using a cohort-based dose-escalation design.
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| AUC |
AUC will be determined by evaluating the pharmacokinetic profile, in which the liposome in the blood will be quantified. |
| From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose). |
| T1/2(z) | Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Liposome in fasting condition. | From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose). |