Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults

Cristalia

Status and phase

Begins enrollment in 6 months

Phase 1

Conditions

Healthy Adult

Overdose Antidote

Treatments

Drug: liposome dispersion

Study type

Interventional

Funder types

Industry

Identifiers

NCT07375498

CRT115

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.