Healthy Adult, Overdose Antidote
Conditions
Keywords
pharmacokinetic, safety
Brief summary
This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.
Detailed description
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.
Interventions
DRUGliposome dispersion
liposome rescue
Sponsors
Cristália Produtos Químicos Farmacêuticos Ltda.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Sign the informed consent form (ICF). * Age ≥ 18 years and ≤ 30 years. * Body mass index (BMI) between 18.5 and 30.0 kg/m². * Be able to complete the study in accordance with the protocol requirements. * Health status: no mental disorders and no history of diseases of the cardiovascular, nervous, respiratory, digestive, urinary, or endocrine systems, and no metabolic abnormalities. * Willingness to use effective contraception.
Exclusion criteria
* Having donated blood within 6 months prior to admission or having experienced significant blood loss (\> 450 mL). * Having participated in any clinical trial involving investigational drugs within 6 months prior to admission in the study. * Positive test for hepatitis B, hepatitis C, syphilis, and/or HIV. * Safety laboratory values outside the normal reference range.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Treatment Related Adverse Events | From enrollment to the end of treatment at 2 weeks. | 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." |
| Safety: Number of Clinically Significant (CS) Changes in Physical Examination. | From enrollment to the end of treatment at 2 weeks. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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). | The Maximal Plasma Concentration (Cmax) after a single dose of liposome in fasting conditions. |
| AUC | 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). | AUC will be determined by evaluating the pharmacokinetic profile, in which the liposome in the blood will be quantified. |
| T1/2(z) | 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). | Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Liposome in fasting condition. |
Countries
Brazil
Contacts
CONTACTDaniele Hamamoto
Outcome results
None listed