Trial reportBritish journal of clinical pharmacology2018
Safety, tolerability and pharmacokinetics/pharmacodynamics of the adrenomedullin antibody adrecizumab in a first-in-human study and during experimental human endotoxaemia in healthy subjects.
Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04252937 (A Dose Escalation Evaluation of Safety and Tolerability of Adrecizumab - a Humanized Monoclonal Antibody Against Adrenomedullin), which is not on this map. Cited by 30 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Dose Escalation Evaluation of Safety and Tolerability of Adrecizumab - a Humanized Monoclonal Antibody Against Adrenomedullin (ADM) in Patients With Acute Heart Failure Requiring Hospitalization
Who cites it
30 citing papers in PubMed, 44 citations in OpenAlex.
- The ADESTE trial: A phase 2 study of enibarcimab, a monoclonal antibody targeting adrenomedullin, in acute heart failure.ESC heart failure · 2025Trial
- Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial.Intensive care medicine · 2021Trial
- Safety, tolerability and pharmacokinetics/pharmacodynamics of the adrenomedullin antibody adrecizumab in a first-in-human study and during experimental human endotoxaemia in healthy subjects.British journal of clinical pharmacology · 2018Trial
- Mathematical model of the inflammatory response to acute and prolonged lipopolysaccharide exposure in humans.NPJ systems biology and applications · 2024Article
- Sandwich immunoassay for adrenomedullin precursor and its practical application.Scientific reports · 2024Article
- Preclinical and first-in-human safety studies on a novel magnetism-based haemofiltration method.Scientific reports · 2024Article
- Targeting lymphatic function in cardiovascular-kidney-metabolic syndrome: preclinical methods to analyze lymphatic function and therapeutic opportunities.Frontiers in cardiovascular medicine · 2024Review
- Protein Biomarkers of Early Menopause and Incident Cardiovascular Disease.Journal of the American Heart Association · 2023Article
- [Individualized treatment in anesthesiology and intensive care medicine].Die Anaesthesiologie · 2023Review
- Clinical Potential of Adrenomedullin Signaling in the Cardiovascular System.Circulation research · 2023Review
- Recent Advances in Monoclonal Antibody-Based Approaches in the Management of Bacterial Sepsis.Biomedicines · 2023Review
- Utility of Measuring Circulating Bio-Adrenomedullin and Proenkephalin for 30-Day Mortality Risk Prediction in Patients with COVID-19 and Non-COVID-19 Interstitial Pneumonia in the Emergency Department.Medicina (Kaunas, Lithuania) · 2022Observational
- 30 Days Mortality Prognostic Value of POCT Bio-Adrenomedullin and Proenkephalin in Patients with Sepsis in the Emergency Department.Medicina (Kaunas, Lithuania) · 2022Observational
- Sustained Activation of CLR/RAMP Receptors by Gel-Forming Agonists.International journal of molecular sciences · 2022Article
- Biomarkers for the Prediction and Judgement of Sepsis and Sepsis Complications: A Step towardsJournal of clinical medicine · 2022Review
- Adrenomedullin Improves Cardiac Remodeling and Function in Obese Rats with Hypertension.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Adrenomedullin Therapy in Moderate to Severe COVID-19.Biomedicines · 2022Review
- Effects of enrichment strategies on outcome of adrecizumab treatment in septic shock:Frontiers in medicine · 2022Article
- Observational
- Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3.Journal of internal medicine · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsAdrenomedullin (ADM) is an important regulator of endothelial barrier function and vascular tone, and may represent a novel treatment target in sepsis. The non-neutralizing ADM antibody adrecizumab has shown promising results in preclinical sepsis models. In the present study, we investigated the safety, tolerability and pharmacokinetics (PK)/pharmacodynamics of adrecizumab in a first-in-man study and in a second study during experimental human endotoxaemia.
methodsForty-eight healthy male volunteers were enrolled in two randomized, double-blind, placebo-controlled phase I studies. In both studies, subjects received placebo or one of three doses of adrecizumab (n = 6 per group). In the second study, a bolus of 1 ng kg
resultsAdrecizumab showed an excellent safety profile in both studies. PK analyses showed proportional increases in the maximum plasma concentration of adrecizumab with increasing doses, a small volume of distribution, a low clearance rate and a terminal half-life of ~14 days. adrecizumab elicited a pronounced increase in plasma ADM levels, whereas levels of mid-regional pro-adrenomedullin remained unchanged, indicating that de novo synthesis of ADM was not influenced. In the second study, no effects of adrecizumab on cytokine clearance were observed, whereas endotoxin-induced flu-like symptoms resolved more rapidly.
conclusionsAdministration of adrecizumab is safe and well tolerated in humans, both in the absence and presence of systemic inflammation. These findings pave the way for further investigation of adrecizumab in sepsis patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.