Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers

Ikaria

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: High Cholesterol

Treatments: Drug: RN5681; Drug: Placebo control

Study type: Interventional

Funder types: Industry

Identifiers

NCT07347678

RN5681-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) 18 to 35 kg/m2
• Fasting LDL-C ≥70 mg/dL (1.81 mmol/L) (all SAD cohorts); fasting LDL-C ≥100 mg/dL (2.59 mmol/L) (POC cohort only)
• Lp(a) at Screening: SAD cohort: ≥25 nmol/L POC cohort: ≥100 nmol/L
• Fasting triglycerides <400 mg/dL (4.51 mmol/L) at Screening
• No clinically significant abnormalities of hepatic or renal function

Exclusion criteria

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal at screening
• Hemoglobin A1c (HbA1c) ≥6.5% at screening
• Current regular smoker (defined as >2 cigarettes/day or >10 cigarettes/week) within 3 months prior to screening
• Use of any siRNA, antisense oligonucleotide (ASO), cell and gene therapy, or clustered regularly interspaced short palindromic repeats (CRISPR) agent in the prior 12 months
• Received any prescription lipid-lowering medication, including but not limited to statins, ezetimibe, and PCSK9 inhibitors to alter serum lipids within 30 days before screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

RN5681

Experimental group

Description:

Drug: RN5681 Investigational product subcutaneous injections

Treatment:

Drug: RN5681

Placebo

Placebo Comparator group

Description:

Drug: Placebo control 0.9% normal saline subcutaneous injection

Treatment:

Drug: Placebo control