relaxin (mRNA-0184) / AstraZeneca, Moderna - LARVOL DELTA

mRNA-CRTX-002: A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date

In vivo immune engineering via mRNA therapeutics: reprogramming the post-infarction cardiac microenvironment. (PubMed, Front Immunol) - "(i) Strategies for mRNA design, encompassing nucleoside modifications and purification techniques, are primarily aimed at circumventing detection by innate immune sensors within inflamed myocardial tissue; (ii) The concept of trained immunity is investigated, focusing on how transient expression of mRNA encoding epigenetic editors may potentially erase pathological epigenetic imprints in myeloid progenitor cells; (iii) Immune cell reprogramming is examined, addressing the myeloid lineage through macrophage polarization and the degradation of neutrophil extracellular traps via metabolic and transcriptional reprogramming, as well as the lymphoid lineage through transient CAR-T cells, in situ-induced regulatory T cells, and regulatory B cells, with an emphasis on the role of cardiomyocytes as paracrine signaling hubs; (iv) The optimization of lipid nanoparticle (LNP) delivery technology is discussed, including SORT-based organ-targeting strategies and the immunogenicity..."

IO biomarker • Journal • Preclinical • Review • Cardiovascular • Fibrosis • Gene Therapies • Immune Modulation • Immunology • Myocardial Infarction

mRNA-CRTX-002: A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date

Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed

Trial completion

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | N=98 ➔ 48

Enrollment change • Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure

Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Feb 2025 ➔ Jul 2025 | Trial primary completion date: Feb 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date

mRNA-CRTX-002: A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P1 trial

Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Jul 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date

Translational pharmacokinetic/pharmacodynamic model for mRNA-0184, an investigational therapeutic for the treatment of heart failure. (PubMed, Clin Transl Sci) - "The preclinical PK/PD model was then scaled allometrically to determine the human mRNA-0184 dose that would achieve therapeutic levels of Rel2-vlk protein expression in patients with stable HF with reduced ejection fraction. Model-based simulations derived from the scaled PK/PD model support the selection of 0.025 mg/kg as an appropriate starting human dose of mRNA-0184 to achieve average trough relaxin levels between 1 and 2.5 ng/mL, which is the potential exposure for cardioprotective action of relaxin."

Journal • PK/PD data • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P1 trial

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: May 2024 ➔ Mar 2025

Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: ModernaTX, Inc.

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure