Phase 1 Clinical Study of the Safety and Pharmacokinetics of Rescue Liposome in Healthy Adult Participants
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Safety: Number of Treatment Related Adverse Events
Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
CRIS115 treatment
Injectable liposomal dispersion with a concentration of 22.08 mg/mL
Intervention: liposome dispersion (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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).)