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NCT Number: NCT07375498

Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults

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

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Key information

Conditions

Healthy Adult Overdose Antidote

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liposome dispersion

Drug

liposome rescue

Primary outcomes

  1. Safety: Number of Treatment Related Adverse Events

    Time frame: 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."

  2. Safety: Number of Clinically Significant (CS) Changes in Physical Examination.

    Time frame: 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 outcomes

  1. 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).

    The Maximal Plasma Concentration (Cmax) after a single dose of liposome in fasting conditions.

  2. 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).

    AUC will be determined by evaluating the pharmacokinetic profile, in which the liposome in the blood will be quantified.

  3. 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).

    Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Liposome in fasting condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Hamamoto

CONTACT

[email protected]

55 19 3795-1100

Sponsors and collaborators

Lead sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Industry

Registry information

Official study title

Phase 1 Clinical Study of the Safety and Pharmacokinetics of Rescue Liposome in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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