Healthy AdultPhase 1NCT07375498
Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults
A Phase 1 study testing liposome dispersion in people with Healthy Adult and Overdose Antidote, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
Trial summary
This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Overdose Antidote
- What is being tested?
- liposome dispersion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2026to 20 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Daniele Hamamoto
Campinas, São Paulo
Daniele Hamamoto, daniele.hamamoto@cristalia.com.br
55 (19) 3795-1100 ext. 1249, daniele.hamamoto@cristalia.com.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adult, Overdose Antidote
- Being tested
- liposome dispersion
- Keywords
- pharmacokinetic, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposome dispersionDrug
liposome rescue
| Study group | Role | What they receive |
|---|---|---|
| CRIS115 treatment | Experimental | Injectable liposomal dispersion with a concentration of 22.08 mg/mL Receives: Drug: liposome dispersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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).
Measured: From enrollment to the end of treatment at 2 weeks.
Secondary outcomes (3)
Cmax
The Maximal Plasma Concentration (Cmax) after a single dose of liposome in fasting conditions.
Measured: 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
AUC will be determined by evaluating the pharmacokinetic profile, in which the liposome in the blood will be quantified.
Measured: 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)
Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Liposome in fasting condition.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375498
- Sponsor's protocol ID
- CRT115
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Study of the Safety and Pharmacokinetics of Rescue Liposome in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07375498
- Acronym / sponsor ID
- CRT115
- Conditions
- Healthy Adult, Overdose Antidote
- Keywords
- pharmacokinetic, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CRIS115 treatment | Experimental | Drug: liposome dispersionInjectable liposomal dispersion with a concentration of 22.08 mg/mL |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposome dispersionliposome rescue | Drug | CRIS115 treatment |
Primary outcome
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."
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).
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liposome dispersion in people with Healthy Adult and Overdose Antidote, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniele Hamamoto (55 19 3795-1100, daniele.hamamoto@cristalia.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Treatment Related Adverse Events (time frame: From enrollment to the end of treatment at 2 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.