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A clinical study to evaluate the safety, tolerability, and pharmacokinetics of the MMP 12 inhibitor FP- 025 after multiple oral ascending dose administration, and to evaluate the effect of food after a single oral dose administration in healthy subjects

Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…

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 randomized, double blind, placebo-controlled single ascending dose study on the safety, tolerability, pharmacokinetics and pharmacodynamics of ACT017 in healthy volunteers

PRIMARY OBJECTIVETo evaluate the safety and tolerability of single ascending, intravenous doses of ACT017 administered as a 6-hour intravenous (i.v.) infusionSECONDARY OBJECTIVES* To evaluate the pharmacokinetics of single ascending, intravenous…

A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH)

Primary objective:- To determine the effect of LIK066 on Liver Function test after 12 weeks of treatmentSecondary objectives: - To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment- To determine the effect of LIK066 on…

A double-blind randomized placebo-controlled single and multiple ascending doses study of the safety and tolerability, pharmacokinetics (including bioavailability comparison and food effect) and pharmacodynamics of oral BMS-986251 administration in healthy subjects, with efficacy assessment of multiple doses in patients with moderate-to-severe psoriasis

The purpose of Part A of this study is to investigate how safe the new compound BMS 986251 is when it is administered as a single dose to healthy subjects. The purpose of Part B of this study is to investigate how safe the new compound BMS 986251 is…

Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes: a randomized controlled pilot trial.

The primary objective of this pilot trial is to explore the difference between the intervention and control group in change from baseline (T0) to the end of therapy (T1) in therapy efficacy of the primary study outcome fatigue assessed by Checklist…

A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections

To assess the efficacy of secukinumab 300 mg s .c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14

A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects

The purpose of the study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect…

Bilateral vs. unilateral transcranial magnetic stimulation of the primary motor cortex to treat chronic orofacial pain: a pilot study with a randomized controlled design

In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect…

A Randomized, Placebo-Controlled, Double-Blind, Parallel Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of LTI-291 in Patients with Parkinson*s Disease and a GBA1 Mutation

The main objectives of this study are:To evaluate the safety and tolerability of three oral dose levels of LTI-291 following 28 days of LTI-291 treatment in patients with GBA-PDTo characterize the plasma and CSF pharmacokinetics (PK) of LTI-291…

Acute effects of 40 mg cortisol on emotion and cognition.

To investigate acute effects of a single 40 mg dose hydrocortisone, compared with placebo, on stress and various aspects of attention and other cognitive processing of emotionally relevant stimuli in healthy anxious young females. The main question…

A Phase 1, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study of MVT-602 in Healthy Premenopausal Women

PrimarySafety and tolerability of MVT-602 following single dose subcutaneous administration in healthy premenopausal womenSecondaryPharmacokinetics (PK) and pharmacodynamics (PD) of MVT-602 following single dose subcutaneous administration

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-DOSE ESCALATION, MULTIPLE-DOSE ESCALATION, AND FOOD EFFECT STUDY OF FLX475 IN HEALTHY MALE AND FEMALE SUBJECTS

The purpose of this study is to investigate how safe the new compound FLX475 is when it is administered to healthy subjects. FLX475 has not been administered to humans before. It has been previously tested in the laboratory and on animals. FLX475…

A randomized, double-blind, repeat dose cross-over study
to assess the bronchodilator effects of once daily QVM149
following morning or evening dosing for 14 days compared
to placebo in patients with asthma

To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.

A first-in-human, single-centre, placebo-controlled, randomized, double-blind study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND567

The primary objective is to determine the safety and tolerability of KAND567 following oral single ascending dose (SAD) and multiple ascending doses (MAD) administration in healthy young and elderly subjects.

Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])

1. The primary objective is to assess the effects of four 250 mg PC-mAB (also referred to as "3G10") once monthly intravenous injections on monocyte function ex vivo. The secondary objectives are to:1. assess the functional effects of 3G10…

Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…

BLUE LIGHT THERAPY FOR SLEEP IMPAIRMENT IN PARKINSON*S DISEASE - Pilot Study -

1. Primary Objective:The primary objective is to evaluate the efficacy of Propeaq light therapy glasses with integrated blue LED lights on sleep disorders in patients with PD using the PSQI. 2. Secondary Objectives: The secondary objective of the…

Double blind, randomized, 2-way cross-over, placebo controlled study to evaluate the therapeutic and preventive effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model in healthy male subjects

PrimaryTo assess the preventative effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model using HPTol upon multiple dosing of GLPG1205 versus placebo.SecondaryTo further assess the preventative effect…

Effects of Modafinil and Caffeine on vigilance in low, medium and high caffeine consumers during the circadian trough in healthy RNLAF aircrew: a randomized controlled trial

To investigate the effect of modafinil (200 mg) and caffeine (300 mg) on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue.