Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: liposome dispersion.
- Who it may be relevant to
- Registry conditions: Healthy Adult, Overdose Antidote. Basic parameters: 18 years — 35 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1 Clinical Study of the Safety and Pharmacokinetics of Rescue Liposome in Healthy Adult Participants
Overview
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
- Drug liposome dispersion
liposome rescue
Primary outcome measures
- Safety: Number of Treatment Related Adverse Events [Time frame: From enrollment to the end of treatment at 2 weeks.]
- Safety: Number of Clinically Significant (CS) Changes in Physical Examination. [Time frame: From enrollment to the end of treatment at 2 weeks.]
Secondary outcome measures (3)
- Cmax [Time frame: 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 [Time frame: 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) [Time frame: 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Daniele Hamamoto — Campinas
Identifiers
NCT: NCT07375498 · CRT115