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NCT ID: NCT03285620 Completed - Hepatitis B Clinical Trials

A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants

Start date: September 7, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose administration of AL-034 in healthy adult participants. The aim is to examine the safety (including pharmacodynamic [PD] biomarker assessments), tolerability, and pharmacokinetics (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs) (Part 2) of AL-034. The potential food effect will be investigated in healthy adult participants at one or optionally 2 single dose level(s).

NCT ID: NCT03283085 Completed - Ulcerative Colitis Clinical Trials

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

NCT ID: NCT03282851 Completed - Healthy Clinical Trials

Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

Start date: November 27, 2017
Phase: Phase 1
Study type: Interventional

This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.

NCT ID: NCT03254368 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

Start date: September 12, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.

NCT ID: NCT03251339 Completed - Healthy Clinical Trials

Safety and Immunogenicity of MSB11455 in Healthy Participants

Start date: August 21, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.

NCT ID: NCT03251092 Completed - Clinical trials for Healthy Volunteer - Complete

Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis

Start date: July 17, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups. The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data. Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose. Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group. Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days. Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days. Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.

NCT ID: NCT03235375 Completed - Renal Insufficiency Clinical Trials

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

Start date: October 27, 2017
Phase: Phase 1
Study type: Interventional

A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

NCT ID: NCT03233360 Completed - Clinical trials for Hepatocellular Carcinoma

Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

INSIGHT
Start date: April 17, 2017
Phase:
Study type: Observational

The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific') registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.

NCT ID: NCT03218917 Completed - Clinical trials for Non-Cystic Fibrosis Bronchiectasis

Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

Start date: October 31, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

NCT ID: NCT03214367 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY900014 in Participants With Type 1 Diabetes

PRONTO-T1D
Start date: July 17, 2017
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).