Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults

February 2, 2026 updated by: Cristália Produtos Químicos Farmacêuticos Ltda.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRIS115 treatment
Injectable liposomal dispersion with a concentration of 22.08 mg/mL
Drug: liposome dispersion
liposome rescue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
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.

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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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)
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRT115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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