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NOT YET RECRUITING
NCT07858019
PHASE1

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

Sponsor: Corsera Health

View on ClinicalTrials.gov

Summary

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 injections (Part B). * Visit the clinic for checkups and tests before the trial starts, complete a 3-night in-patient stay, followed by 14 follow up visits (monthly) until the trial ends (approximately 13 months).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-10

Completion Date

2028-05

Last Updated

2026-10-05

Healthy Volunteers

Yes

Interventions

DRUG

COR-2003

A single dose of COR-2003 will be administered subcutaneously

DRUG

Placebo

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study

DRUG

COR-1004 + COR-2003

A single dose of COR-1004 and a single dose of COR-2003 will be co-administered subcutaneously

DRUG

Placebo + Placebo

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study

Locations (2)

Veritus

Melbourne, Australia

NZCR

Auckland, New Zealand