 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
- || AZD8233 / AstraZeneca
PK/PD data, Journal: Population pharmacokinetics of a novel PCSK9 antisense oligonucleotide. (Pubmed Central) - Mar 20, 2024
P1, P1/2,
Covariate analysis showed body weight to be the main factor affecting exposure to AZD8233, which largely explained the higher Cmax observed in the Asian population relative to non-Asians.
- | AZD8233 / AstraZeneca
Phase classification: SOLANO: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia (clinicaltrials.gov) - Dec 15, 2023
P2, N=411, Completed, Sponsor: AstraZeneca
Covariate analysis showed body weight to be the main factor affecting exposure to AZD8233, which largely explained the higher Cmax observed in the Asian population relative to non-Asians. Phase classification: P2b --> P2
- | AZD8233 / AstraZeneca
Preclinical, Journal: In Vivo Metabolite Profiles of a GalNAc Conjugated Antisense Oligonucleotide AZD8233 Using Liquid Chromatography-High Resolution Mass Spectrometry: a Cross Species Comparison in Animals and Humans. (Pubmed Central) - Sep 18, 2023
A biotransformation strategy for ASO drug candidates was established by utilizing tissue, plasma and urine samples collected from toxicology and/or clinical studies and LC-high-resolution mass spectrometry analysis without conducting bespoke radiolabeled ADME studies. The generated biotransformation package was considered adequate by health authorities to progress AZD8233 into a phase 3 programme, proving its applicability to future metabolism studies of ASO candidates in drug development.
- ||| AZD8233 / AstraZeneca
Trial termination: To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants. (clinicaltrials.gov) - Dec 22, 2022
P1, N=3, Terminated, Sponsor: AstraZeneca
The generated biotransformation package was considered adequate by health authorities to progress AZD8233 into a phase 3 programme, proving its applicability to future metabolism studies of ASO candidates in drug development. Active, not recruiting --> Terminated; A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.
- || Review, Journal: Recent Advances in Gene Therapy for Familial Hypercholesterolemia: An Update Review. (Pubmed Central) - Nov 27, 2022
With gene editing technologies, such as CRISPR-Cas 9 and meganuclease, completing animal experiments in mice or cynomolgus monkeys and demonstrating lasting lipid-lowering effects, patients with FH are expected to reach a permanent cure in the future. (4) Gene therapy is being widely used for the lipid-lowering treatment of FH patients and has shown excellent therapeutic promise, but the current delivery efficiency, economic burden, immunogenicity and the precision of gene therapy can be further optimized.
- || AZD8233 / AstraZeneca
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants. (clinicaltrials.gov) - Oct 17, 2022
P1, N=3, Active, not recruiting, Sponsor: AstraZeneca
(4) Gene therapy is being widely used for the lipid-lowering treatment of FH patients and has shown excellent therapeutic promise, but the current delivery efficiency, economic burden, immunogenicity and the precision of gene therapy can be further optimized. Recruiting --> Active, not recruiting | N=24 --> 3 | Trial completion date: Oct 2023 --> Nov 2022 | Trial primary completion date: Oct 2023 --> Nov 2022
- | AZD8233 / AstraZeneca
Journal: AZD8233 Antisense Oligonucleotide targeting PCSK9 does not prolong QT interval AZD8233 ASO C-QT analysis. (Pubmed Central) - Oct 14, 2022
Recruiting --> Active, not recruiting | N=24 --> 3 | Trial completion date: Oct 2023 --> Nov 2022 | Trial primary completion date: Oct 2023 --> Nov 2022 As the effect on ΔΔQTcF is below the threshold for regulatory concern (10 ms), it can be concluded that AZD8233 does not induce QTcF prolongation at the high clinical exposure scenario.
- ||| AZD8233 / AstraZeneca
Trial completion: HAYATE: A Study of AZD8233 in Participants With Dyslipidemia. (clinicaltrials.gov) - Oct 4, 2022
P1/2, N=87, Completed, Sponsor: AstraZeneca
As the effect on ΔΔQTcF is below the threshold for regulatory concern (10 ms), it can be concluded that AZD8233 does not induce QTcF prolongation at the high clinical exposure scenario. Active, not recruiting --> Completed
- ||||| AZD8233 / AstraZeneca
Clinical: ION449 (an antisense drug to lower plasma PCSK9) falls short of AstraZeneca’s efficacy criteria despite reaching its phase 2 trial primary endpoint with a p-value of 0.001 & achieving a 62.3% reduction in LDL-C after 28 weeks compared to placebo. https://t.co/OeYfmwTYmX (Twitter) - Sep 27, 2022
- |||| AZD8233 / AstraZeneca
Trial completion: SOLANO: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia (clinicaltrials.gov) - Sep 6, 2022
P2b, N=411, Completed, Sponsor: AstraZeneca
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || AZD8233 / AstraZeneca
Enrollment open: To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants. (clinicaltrials.gov) - Aug 31, 2022
P1, N=24, Recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- || AZD8233 / AstraZeneca
Trial completion date, Trial initiation date, Trial primary completion date: To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants. (clinicaltrials.gov) - Jul 29, 2022
P1, N=24, Not yet recruiting, Sponsor: AstraZeneca
Not yet recruiting --> Recruiting Trial completion date: Apr 2023 --> Oct 2023 | Initiation date: Nov 2021 --> Jul 2022 | Trial primary completion date: Apr 2023 --> Oct 2023
- || AZD8233 / AstraZeneca
Enrollment closed: HAYATE: A Study of AZD8233 in Participants With Dyslipidemia. (clinicaltrials.gov) - Jun 8, 2022
P1/2, N=87, Active, not recruiting, Sponsor: AstraZeneca
Trial completion date: Apr 2023 --> Oct 2023 | Initiation date: Nov 2021 --> Jul 2022 | Trial primary completion date: Apr 2023 --> Oct 2023 Recruiting --> Active, not recruiting
- ||| AZD8233 / AstraZeneca
آسترازينيكا @AstraZeneca تطرح نتائج أولية للتجارب الإكلينيكية المرحلة الثانية للدواء التجريبي لعلاج الكوليسترول 💉AZD8233 💉حقنة واحدة تحت الجلد شهريا 🗓بعد12أسبوع (مايعادل اتمام تلقي ٣ جرعات) ✅⬇️انخفض الكوليسترول "الضار" LDL بنسبة73% https://t.co/MHsLNyO9xe 3️⃣ (Twitter) - Apr 5, 2022
- || AZD8233 / AstraZeneca
Trial completion date, Trial primary completion date: HAYATE: A Study of AZD8233 in Participants With Dyslipidemia. (clinicaltrials.gov) - Feb 23, 2022
P1/2, N=87, Recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Trial completion date: Apr 2022 --> Aug 2022 | Trial primary completion date: Apr 2022 --> Aug 2022
- || AZD8233 / AstraZeneca
Clinical, Journal: High-sensitivity workflow for LC-MS-based analysis of GalNAc-conjugated oligonucleotides: a case study. (Pubmed Central) - Jan 27, 2022
A high-sensitivity methodology for mass-specific measurement of AZD8233, a GalNAc-conjugated 16-mer oligonucleotide, using LLE-SPE with optimized LC conditions and detection of a low-mass fragment ion was successfully validated in the range of 0.20-100 ng/ml in human plasma. The AZD8233 LC-MS methodology adds valuable insight on the GalNAc linker's in vivo stability to the program and should be broadly applicable to oligonucleotides requiring high sensitivity and mass-selective measurement for quantitative discrimination from metabolites and endogenous interferences.
- ||| AZD8233 / AstraZeneca
Enrollment closed: SOLANO: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia (clinicaltrials.gov) - Oct 19, 2021
P2b, N=409, Active, not recruiting, Sponsor: AstraZeneca
The AZD8233 LC-MS methodology adds valuable insight on the GalNAc linker's in vivo stability to the program and should be broadly applicable to oligonucleotides requiring high sensitivity and mass-selective measurement for quantitative discrimination from metabolites and endogenous interferences. Recruiting --> Active, not recruiting
- || AZD8233 / AstraZeneca
New P1 trial: To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants. (clinicaltrials.gov) - Oct 3, 2021
P1, N=28, Not yet recruiting, Sponsor: AstraZeneca
- ||| AZD8233 / AstraZeneca
Trial completion: A Study of AZD8233 in Participants With Dyslipidemia (clinicaltrials.gov) - Aug 12, 2021
P2b, N=119, Completed, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||| AZD8233 / AstraZeneca
Enrollment open: SOLANO: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia (clinicaltrials.gov) - Jul 28, 2021
P2b, N=376, Recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||| AZD8233 / AstraZeneca
New P2b trial: SOLANO: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia (clinicaltrials.gov) - Jul 15, 2021
P2b, N=376, Not yet recruiting, Sponsor: AstraZeneca
- || AZD8233 / AstraZeneca
Trial completion: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Jun 30, 2021
P1, N=34, Completed, Sponsor: AstraZeneca
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||| AZD8233 / AstraZeneca
New P1/2 trial: HAYATE: A Study of AZD8233 in Participants With Dyslipidemia. (clinicaltrials.gov) - Apr 1, 2021
P1/2, N=91, Recruiting, Sponsor: AstraZeneca
- |||| AZD8233 / AstraZeneca
Clinical: Ionis’s ION449 PCSK9 program is the first example of a liver LICA antisense oligonucleotide (ASO) to advance to oral clinical development. #OPTBoston (Twitter) - Mar 30, 2021
- || AZD8233 / AstraZeneca
Enrollment closed: A Study of AZD8233 in Participants With Dyslipidemia (clinicaltrials.gov) - Feb 23, 2021
P2b, N=119, Active, not recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| AZD8233 / AstraZeneca
Trial completion: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Jan 25, 2021
P1, N=73, Completed, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || AZD8233 / AstraZeneca
Enrollment closed, Enrollment change: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Jan 19, 2021
P1, N=34, Active, not recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=49 --> 34
- ||||| AZD8233 / AstraZeneca
New P2b trial: A Study of AZD8233 in Participants With Dyslipidemia (clinicaltrials.gov) - Nov 22, 2020
P2b, N=108, Recruiting, Sponsor: AstraZeneca
- || AZD8233 / AstraZeneca
Enrollment change: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Sep 23, 2020
P1, N=73, Active, not recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting | N=49 --> 34 N=56 --> 73
- AZD8233 / AstraZeneca
[VIRTUAL] Single Dose Safety, Pharmacokinetics, and Pharmacodynamics of a Potent PCSK9 Synthesis Inhibitor, AZD8233, in Subjects With Elevated Ldl Cholesterol (OnDemand) - Sep 17, 2020 - Abstract #AHA2020AHA_160;
P1
The safety, PK and PD support further evaluation of AZD8233 in multiple ascending dose studies. The PD data indicate that a high level of PCSK9 and LDL-C reduction can be maintained over a dose interval of once monthly or less frequent at a dose below 100mg.
- || AZD8233 / AstraZeneca
Enrollment change: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Sep 13, 2020
P1, N=49, Recruiting, Sponsor: AstraZeneca
The PD data indicate that a high level of PCSK9 and LDL-C reduction can be maintained over a dose interval of once monthly or less frequent at a dose below 100mg. N=33 --> 49
- || AZD8233 / AstraZeneca
Enrollment open: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Jun 8, 2020
P1, N=33, Recruiting, Sponsor: AstraZeneca
N=33 --> 49 Active, not recruiting --> Recruiting
- || AZD8233 / AstraZeneca
Trial completion date, Trial primary completion date: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - May 21, 2020
P1, N=56, Active, not recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Recruiting Trial completion date: Aug 2020 --> Nov 2020 | Trial primary completion date: Aug 2020 --> Nov 2020
- || AZD8233 / AstraZeneca
Enrollment closed: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Apr 23, 2020
P1, N=33, Active, not recruiting, Sponsor: AstraZeneca
Trial completion date: Aug 2020 --> Nov 2020 | Trial primary completion date: Aug 2020 --> Nov 2020 Recruiting --> Active, not recruiting
- || AZD8233 / AstraZeneca
Trial completion date, Trial primary completion date: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Jan 2, 2020
P1, N=56, Active, not recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020
- || AZD8233 / AstraZeneca
Enrollment open: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Dec 2, 2019
P1, N=33, Recruiting, Sponsor: AstraZeneca
Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020 Not yet recruiting --> Recruiting
- || AZD8233 / AstraZeneca
New P1 trial: To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia (clinicaltrials.gov) - Nov 14, 2019
P1, N=33, Not yet recruiting, Sponsor: AstraZeneca
- | AZD8233 / AstraZeneca
Enrollment closed: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Sep 19, 2019
P1, N=56, Active, not recruiting, Sponsor: AstraZeneca
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- | AZD8233 / AstraZeneca
Enrollment open, Trial completion date, Trial primary completion date: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Aug 4, 2019
P1, N=56, Recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting | Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Aug 2019 --> Dec 2019
- || AZD8233 / AstraZeneca
Enrollment closed: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - May 13, 2019
P1, N=48, Active, not recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Recruiting | Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Aug 2019 --> Dec 2019 Recruiting --> Active, not recruiting
- ||| AZD8233 / AstraZeneca
Enrollment open: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Aug 20, 2018
P1, N=56, Recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| AZD8233 / AstraZeneca
New P1 trial: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels. (clinicaltrials.gov) - Jul 19, 2018
P1, N=56, Not yet recruiting, Sponsor: AstraZeneca