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NCT ID: NCT05029518 Completed - Healthy Volunteers Clinical Trials

3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability

Start date: September 9, 2021
Phase: Phase 1
Study type: Interventional

This is a single center, Phase 1, randomized, open-label, single-dose, 3 treatment, 3-period, 6-sequence, crossover study designed to compare the PK of SMP-100 dissolved in water for oral administration with SMP-100 tablets under fasting conditions, and to evaluate the effect of food on the bioavailability of SMP-100 tablets in healthy subjects.

NCT ID: NCT05026008 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375

Start date: September 30, 2021
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers

NCT ID: NCT05023525 Completed - Healthy Clinical Trials

A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase I, single-dose escalation clinical trial for HSK31858 conducted in healthy volunteers. The safety, tolerability, and pharmacokinetics of HSK31858 tablet in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

NCT ID: NCT05022771 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015

Start date: October 14, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after Single ascending doses (SAD).

NCT ID: NCT05021978 Completed - Essential Tremor Clinical Trials

A Clinical Trial of PRAX-944 in Participants With Essential Tremor

Start date: March 3, 2020
Phase: Phase 2
Study type: Interventional

This is a 2-part clinical trial to evaluate the efficacy, safety, and tolerability of 40 and 120 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor. Part A is designed to study the dose titration from 20 to 40 mg every morning (QAM) (ie, 2 weeks with 7 days at each dose level). Part B is designed to study the dose titration from 20 to up to 120 mg QAM with at least 14 days of dosing at the highest tolerated dose for each participant. Blood levels of PRAX-944 will also be measured throughout the trial and pharmacokinetics will be evaluated.

NCT ID: NCT05019950 Completed - Clinical trials for Normal Healthy Volunteers

Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.

NCT ID: NCT05014438 Completed - Dermatitis, Atopic Clinical Trials

A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis

Start date: August 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.

NCT ID: NCT05013359 Completed - Obesity Clinical Trials

Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)

ACTION Teens
Start date: August 23, 2021
Phase:
Study type: Observational

ACTION Teens is a multinational cross-sectional survey-based study. The study consists of a quantitative online survey to be conducted among three groups of respondents in ten countries worldwide. The respondent population will include Adolescents Living with Obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity. The goal of this study is to provide insights to drive awareness around the needs of adolescents living with obesity and their caregivers, as well as to identify key areas of misalignment between adolescents, their caregivers and the HCPs involved in obesity treatment and management. ACTION Teens is designed to generate evidence to identify and address these challenges on both a global and local level, extending the insights from the previously conducted ACTION-IO study.

NCT ID: NCT05013008 Completed - Clinical trials for Type 2 Diabetes Mellitus

An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants

FIGARO-BM
Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD). FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required. Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney. In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion. The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.

NCT ID: NCT05006573 Completed - Clinical trials for Non-cystic Fibrosis Bronchiectasis

Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis

MAHALE
Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI). All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab. The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).