Adrecizumab-LPS Study

Status Completed

Clinical Trial Summary

In this randomized, double-blind, placebo-controlled study, either a single dose of Adrecizumab (0.5, 2.0 or 8.0 mg/kg) or placebo will be administrated to 24 healthy male volunteers during experimental endotoxemia.

Clinical Trial Description

Adrenomedullin (ADM) is a natural occurring 52 amino acid peptide which is mainly expressed in endothelial and smooth muscle cells. ADM plasma levels are increased in patients with sepsis and related with severity of disease. ADM is a key regulator of vasotonus and of endothelial integrity in sepsis. Adrecizumab is an antibody against the N-terminus of ADM which only partially inhibits the bioactivity of ADM. Several septic animal studies have shown that administration of Adrecizumab leads to stabilization of hemodynamics in mice and pigs, improved renal function, reduced catecholamine demand, improved fluid balance and improved survival. The administration of Adrecizumab to rodents, non-human primates and recently humans, has been tolerated very well. The experimental human endotoxemia model, in which healthy male volunteers receive a low dose of lipopolysaccharide (LPS) derived from Escherichia coli, is widely used to study the effects of systemic inflammation in humans in vivo and is considered a safe and highly reproducible method to activate the innate immune system. Furthermore, previous data has shown that experimental human endotoxemia results in increased plasma ADM levels. In this study, the investigators wish to assess the safety, tolerability and pharmacokinetics/-dynamics of Adrecizumab under inflammatory conditions in healthy volunteers. ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT03083171
Study type	Interventional
Source	Adrenomed AG
Contact
Status	Completed
Phase	Phase 1
Start date	January 4, 2017
Completion date	May 24, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05001152` - Taste Assessment of Ozanimod	Phase 1
Completed	`NCT05029518` - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability	Phase 1
Completed	`NCT04493255` - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants	Phase 1
Completed	`NCT03457649` - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers	Phase 1
Completed	`NCT00995891` - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed	`NCT05050318` - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively	Phase 4
Completed	`NCT05043766` - Evaluation of Oral PF614 Relative to OxyContin	Phase 1
Completed	`NCT04466748` - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects	Phase 1
Completed	`NCT00746733` - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Phase 1
Recruiting	`NCT05929651` - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy	Phase 4
Completed	`NCT05954039` - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect	N/A
Completed	`NCT05045716` - A Study of Subcutaneous Lecanemab in Healthy Participants	Phase 1
Active, not recruiting	`NCT02747927` - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children	Phase 3
Completed	`NCT05533801` - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants	Phase 1
Not yet recruiting	`NCT03931369` - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)	Phase 2
Completed	`NCT03279146` - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects	Phase 1
Completed	`NCT06027437` - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants	Phase 1
Recruiting	`NCT05619874` - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity	N/A
Completed	`NCT05553418` - Investigational On-body Injector Clinical Study	N/A
Completed	`NCT04092712` - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers	Phase 1