Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults

Starting soon · Phase 1

Conditions studied: Healthy Adult, Overdose Antidote

In brief

This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.

Key facts

Study ID

NCT07375498

Run by

Cristália Produtos Químicos Farmacêuticos Ltda.

People needed

12

Starts

2026-08-20

Expected to finish

2027-02-20

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Daniele Hamamoto — Campinas, São Paulo, Brazil

Full record on ClinicalTrials.gov

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