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A randomized double-blind placebo-controlled phase 1 study regarding safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM 8101) in healthy male subjects.

To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.

APA12/PANTER* study: ""PTM202 and modulation of host resistance to diarrheagenic Escherichia coli in a randomized placebo-controlled trial in healthy human subjects"

To study whether PTM202, a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg, improves the resistance of humans to traveller*s diarrhea as caused by diarrheagenic E. coli. PTM202 contains specific…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

The effect of Staphefekt on the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

To retrieve (in vivo) data about the effect of Staphefekt on the microbiome, including Staphylococcus aureus, and on disease severity in patients with atopic dermatitis.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…

Hypertonic saline in primary ciliary dyskinesia: a pilot study

We hypothesize that hypertonic saline nebulizations improve respiratory symptoms and quality of life in PCD patients.

Phase 1, randomized, placebo controlled, double blind, single dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects.

To investigate the safety and tolerability of the intravenously applied (directly given into a blood vessel) new test compound.

Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.

Study objective: To evaluate the long-term (cost-)effectiveness of antibiotic treatment added to corticosteroids in the treatment of exacerbations of COPD.

Treatment of peri-implant mucositis; A randomized placebo controlled clinical study

The primary objective of this controlled clinical study is to evaluate the effect of chlorhexidine + CPC rinsing of the oral cavity for treatment of peri-implant mucositis.The secondary objectives are to assess the effectiveness of peri-implant…

The Qure study: Q-fever fatigue syndrome - response to treatment

To assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT).

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

The purpose of the study is to investigate to what extent WCK 4282 is safe and tolerated. It will also be investigated how quickly and to what extent WCK 4282 is absorbed and eliminated from the body (this is called pharmacokinetics).

A randomized, double-blind, placebo-controlled study of ascending single low doses of LPS administered intravenously to healthy volunteers to assess the dose-response relation.

To assess the relationship between administration of low doses of LPS (0.5, 1 and 2 ng/kg bodyweight) and the inflammatory response (cytokine levels and hs-CRP) in healthy male volunteers;To assess the duration of tolerance/paralysis of the immune…

An open label, single dose study to assess the pharmacokinetics of a microdose of recombinant human placental alkaline phosphatase (hRESCAP, part 1) followed by a randomized, double-blind, placebo-controlled, parallel, single ascending dose, first-in-human study to assess safety and tolerability of hRESCAP (part 2) in healthy male volunteers

Part 1:- To assess the PK of a single iv microdose (<=30 nmol) of recombinant human placental alkaline phosphatase (hRESCAP);- To assess if microdosing is a suitable technique to predict the PK of recombinant proteins using hRESCAP as model…

Microbiological and clinical evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a double blind placebo controlled randomized clinical study.

The primary objective of this controlled clinical study is to evaluate the microbiological effect of chlorhexidine + CPC rinsing of the implant surface in the surgical treatment of peri-implantitis. The secondary objectives are to assess both the…

EVALUATION OF SAFETY, TOLERABILITY AND PHARMACOKINETIC CHARACTERISTICS OF MULTIPLE-ASCENDING DOSES OF CG400549 IN HEALTHY VOLUNTEERS

The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body (this is called…

Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a double blind placebo controlled randomized clinical study

The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a placebo. The secondary…

A Phase-II, double-blind, randomized, placebo-controlled study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure.

To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.

An explorative randomised placebo controlled open-label trial of ethanol lock therapy for the treatment of catheter-related bloodstream infections in long term intravascular devices in parenteral nutrition patients (Ethanol lock therapy in TPN patients)

To study the effect of ethanol lock therapy on the cure rate of catheter-related infections (CRIs) and on the incidence of (CRI related) venous thrombosis in total parenteral nutrition (TPN) patients with tunneled central venous catheters older than…