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NCT ID: NCT04677933 Completed - Osteoarthritis Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002

Start date: June 3, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of: - Screening period: up to 14 days (defined as Day -23 to -9) - Washout period: 5 days (± 1 day) (defined as Day -8 to -4) - Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing) - Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing) - Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose) Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms: - Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002 - Arm B: 10 patients will receive 10 µg BIW OLP-1002 - Arm C: 10 patients will receive Placebo BIW

NCT ID: NCT04677543 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ARISE
Start date: December 22, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.

NCT ID: NCT04676711 Completed - Healthy Clinical Trials

A Study of GFH312 in Healthy Subjects

Start date: April 27, 2021
Phase: Phase 1
Study type: Interventional

GFH312 is a small molecule inhibitor of receptor-interacting serine/threonine protein-1(RIP1) kinase, a key regulator of the TNF-α downstream. RIPK1 can regulate the NF- κB signaling and necroptosis, a type of cell death which can trigger immune response and enhance inflammation. As such, GFH312 represents a novel, selective mechanism for the treatment of inflammatory conditions. This study is the first administration of GFH312 to humans. The purpose of the study is to evaluate the safety/tolerability and pharmacokinetics in healthy subjects. The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies. The dose range proposed in this study is based on a low starting dose escalating to supra-therapeutic doses.

NCT ID: NCT04676555 Completed - Clinical trials for Relapsing Forms of Multiple Sclerosis

Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

TIMIOS
Start date: May 11, 2021
Phase:
Study type: Observational

This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.

NCT ID: NCT04674111 Completed - Clinical trials for Coronary Artery Disease

Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

Vortex-FIH
Start date: September 28, 2021
Phase: N/A
Study type: Interventional

Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)

NCT ID: NCT04672460 Completed - Breast Cancer Clinical Trials

A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

Start date: December 21, 2020
Phase: Phase 1
Study type: Interventional

This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.

NCT ID: NCT04669262 Completed - Healthy Clinical Trials

BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants

Start date: December 9, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants

NCT ID: NCT04668664 Completed - Liver Cirrhosis Clinical Trials

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

Start date: April 5, 2021
Phase:
Study type: Observational

The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.

NCT ID: NCT04667377 Completed - Obesity Clinical Trials

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

NCT ID: NCT04664153 Completed - Atopic Dermatitis Clinical Trials

Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

EMPORIA
Start date: December 21, 2020
Phase: Phase 2
Study type: Interventional

This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.