Study of RN0361 in Adult Subjects
- Conditions
- Familial ChylomicronemiaHypertriglyceridemia
- Interventions
- Registration Number
- NCT06471543
- Lead Sponsor
- Ikaria Bioscience Pty Ltd
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics， pharmacodynamics and immunogenicity of single and multiple doses of RN0361 in Adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Willing to provide written informed consent before any study-specific procedures.
- Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol.
- Fasting serum triglyceride levels > 80 mg/dL and fasting LDL-C ≥70 mg/dL at screening
- Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential.
- Participants must avoid sperm or egg donation during the study
- History or presence of any serious or uncontrolled disease
- clinically significant health concerns
- Recent vaccination with live vaccines, except for influenza, or plans to receive such during the study.
- Positive tests for alcohol or drugs of abuse at screening.
- History of multiple drug allergies or allergic reactions to specific components used in the study.
Note: Additional inclusion/exclusion ceiteria may apply, per protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RN0361 RN0361 subcutaneous injections Placebo RN0361 calculated volume to match active treatment
- Primary Outcome Measures
Name Time Method Safety and tolerability of RN0361 as evaluated when administered as single and multiple ascending SC doses in healthy adult subjects with elevated triglycerides Up to Day85 in Single Ascending-Dose (SAD) and Day113 in the Multiple Ascending Dose (MAD) part. Additionally, there may be an extra follow-up period. Incidence and frequency of injection site reactions (ISRs)
- Secondary Outcome Measures
Name Time Method Terminal elimination half-life (t1/2) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Apparent volume of distribution (Vz/F) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Cumulative amount of drug excreted in urine at the end of each interval (Aeu) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1 Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Maximum plasma concentration (Cmax) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Cumulative fraction of dose excreted in the urine over collection intervals (FEu) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1 Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Time to reach maximum plasma concentration (tmax) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Area under the plasma concentration-time curve from time zero to 24h post-dose (AUC0-24) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Elimination rate constant (λz) of single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose plasma PK parameters for RN0361 and its metabolite
Renal clearance (CLR) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1 Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Amount of drug excreted in the urine over the collection interval t (Aet) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1 Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Fraction of dose excreted in the urine over the collection interval (FE) of single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite AS3'N-1 Up to Day 85 in Part 1 [SAD] and Day 113 in Part 2 [MAD]. Additionally, there may be an extra follow-up period. Single-dose and multiple-dose urine PK parameters for RN0361 and its metabolite
Trial Locations
- Locations (1)
Nucleus Network Melbourne
🇦🇺Melbourne, Victoria, Australia