Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults

NCT07375498 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CRT115
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult; Overdose Antidote

Keywords

pharmacokinetic; safety

Outcome Measures

Primary Outcomes (2)

• Safety: Number of Treatment Related Adverse Events

  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.

  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 Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (1)

CRIS115 treatment

EXPERIMENTAL

Injectable liposomal dispersion with a concentration of 22.08 mg/mL

Drug: liposome dispersion

Interventions

liposome dispersion DRUG

liposome rescue

CRIS115 treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead

Study Sites (1)

Daniele Hamamoto

Campinas, São Paulo, Brazil

Location

Central Study Contacts

Daniele Hamamoto

CONTACT

55 19 3795-1100; daniele.hamamoto@cristalia.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 29, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

BR (1)