Clinical Trials Logo

Filter by:
NCT ID: NCT05076149 Completed - Cystic Fibrosis Clinical Trials

A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

Start date: October 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

NCT ID: NCT05064345 Completed - Healthy Clinical Trials

A Study to Evaluate HB0034 in Healthy Adult Participants

Start date: December 3, 2021
Phase: Phase 1
Study type: Interventional

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.

NCT ID: NCT05053334 Completed - Healthy Volunteers Clinical Trials

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair

Start date: February 16, 2022
Phase: Phase 1
Study type: Interventional

A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.

NCT ID: NCT05047484 Completed - Healthy Clinical Trials

A Study of Multiple Doses of ALXN2050 in Healthy Adults

Start date: January 7, 2019
Phase: Phase 1
Study type: Interventional

This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).

NCT ID: NCT05047458 Completed - Healthy Clinical Trials

A Study of Single-dose ALXN2050 in Healthy Adults

Start date: November 28, 2017
Phase: Phase 1
Study type: Interventional

This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.

NCT ID: NCT05033080 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).

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: NCT05011812 Completed - Covid19 Clinical Trials

Study of PBI-0451 in Healthy Subjects.

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

This is a phase 1, placebo-controlled, blinded, randomized, dose escalation study of PBI-0451 in healthy subjects. PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. The study is designed to evaluate the safety, tolerability and pharmacokinetics of PBI-0451 after single and multiple ascending doses and also to explore drug-drug interaction potential of PBI-0451.

NCT ID: NCT05007951 Completed - Covid19 Clinical Trials

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)

Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This is a 2-Stage, Phase III, randomized, active-controlled, observer-blind, parallel-group, multi-center study to compare the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) to ChAdOx1-S in adults aged 18 years and older.

NCT ID: NCT05002946 Completed - Healthy Clinical Trials

Pharmacokinetics of SP-104

Start date: January 11, 2022
Phase: Phase 1
Study type: Interventional

This open-label, 3-period, 3-treatment, randomized study will characterize the pharmacokinetics and safety and tolerability of SP-104 under fasting and fed conditions as compared to the pharmacokinetics of Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects.