AZD2373 / Ionis, AstraZeneca - LARVOL DELTA

Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Nephrology • Renal Disease

Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease (clinicaltrials.gov) - P2 | N=96 | Not yet recruiting | Sponsor: AstraZeneca | Phase classification: P ➔ P2

Phase classification • Trial completion date • Trial initiation date • Trial primary completion date • Nephrology • Renal Disease

Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of AZD2373, an antisense oligonucleotide targeting APOL1 (ERA-EDTA 2024) - P1 | "Repeated doses of AZD2373 were safe and well tolerated, reducing plasma APOL1 concentrations in a dose- and time-dependent manner in healthy males of West African ancestry."

Clinical • PK/PD data • Nephrology • Renal Disease • IFNG

A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=40 ➔ 24

Enrollment change • Enrollment closed

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: AstraZeneca | Terminated ➔ Completed

Trial completion

A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2024 ➔ Jun 2023 | Trial primary completion date: Mar 2024 ➔ Jun 2023

Trial completion date • Trial primary completion date

A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Oct 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date

A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AstraZeneca

New P1 trial

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1; N=30; Terminated; Sponsor: AstraZeneca; N=48 ➔ 30; Trial completion date: Feb 2022 ➔ Jul 2021; Active, not recruiting ➔ Terminated; Trial primary completion date: Feb 2022 ➔ Jul 2021; AZ has decided not to continue this study, since sufficient data are available to support proposed dosing in future studies, and assessment of higher single doses are limited by tolerability due to the development of Injection Site Reactions.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: AstraZeneca; Trial completion date: Aug 2021 ➔ Feb 2022; Trial primary completion date: Aug 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date

"If you connect the dots the undisclosed IONIS-AZ5-2.5Rx, or AZD2373 of $AZN / $IONS sound like APOL1 is the target https://t.co/O4PoRLgDWD" (@jonesallen234)

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: AstraZeneca; Active, not recruiting ➔ Recruiting; Trial completion date: Jan 2021 ➔ Apr 2021; Trial primary completion date: Jan 2021 ➔ Apr 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1; N=48; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: AstraZeneca; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: AstraZeneca

Clinical • New P1 trial