Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects (NCT06471543) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
United States108 participantsStarted 2024-09-30
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.
Who can participate
Age range18 Years – 70 Years
SexALL
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Phase I：
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Phase II:
Inclusion Criteria:
* 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 ≥ 300 mg/dL at screening
* Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male partic…
What they're measuring
1
Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects.
Timeframe: Up to Day85
2
Absolute and percent change from baseline in APOC3 and fasting triglycerides (TG) in subjects with HTG