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Phase 1Not yet recruiting

A Study to Evaluate COR-2003 as Monotherapy and Co-Administered With COR-1004 in Adult Volunteers

A Two-part, Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered COR-2003, as Monotherapy (Part A) and Co-administered With COR-1004 (Part B)

Sponsor
Corsera Health (Industry)
Enrolment
108 planned
Conditions
Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
Interventions
COR-2003; Placebo; COR-1004 + COR-2003; Placebo + Placebo
Ages
adults, older adults
Registry
NCT07858019

Full record on ClinicalTrials.gov

From the registry

This clinical trial has two parts. In Part A, the goal is to learn about the safety and tolerability of COR-2003 when it is given alone. In Part B, the goal is to learn about the safety and tolerability of COR-2003 and COR-1004 when given together. The main questions it aims to answer in Part A are: * How well is COR-2003 absorbed in the blood? * Do any medical problems develop in participants taking COR-2003? * How well do participants tolerate COR-2003 compared to a placebo (a look-alike injection that contains no drug)? The main questions it aims to answer in Part B are: * How well are COR-1004 + COR-2003 absorbed in the blood when dosed at the same time? * Do any medical problems develop in participants taking COR-1004 + COR-2003? * How well do participants tolerate COR-1004 + COR-2003 compared to placebo + placebo (two look-alike injections that contains no drug)? Participants will: * Receive one or two subcutaneous injection(s) of COR-2003 or placebo (Part A) or receive two subcutaneous injections - one injection of COR-2003 and one injection of COR-1004 or two placebo…

Primary outcomes

  • Part A: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study
  • Part B: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study

History

  1. Study completion expected

  2. Primary completion expected

  3. Started

  4. Registered