Clinical trials: Phase I
Acute Lung Injury, Acute Respiratory Distress Syndrome
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
- Trial name
- NCT00789685
- Testing
- Interferon Beta
- Where
- 8 sites in United Kingdom
- Volunteers
- 37 people
- Sponsor
- Faron Pharmaceuticals Ltd
Advanced Solid Tumors
A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors
The proposed clinical trial is a phase I, open-label, multi-center, dose-escalation study of ALT-803 in patients with surgically incurable advanced solid tumors: melanoma, renal cell, non-small cell lung and squamous cell head…
- Trial name
- NCT01946789
- Testing
- ALT-803
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Altor BioScience
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Bipolar Disorder
Lamotrigine Phase III Study in Bipolar I Disorder
This registration study in China is a multi-centre, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of lamotrigine in the prevention of recurrence/relapse of mood episodes in subjects with…
- Trial name
- NCT01602510
- Testing
- Lamotrigine
- Where
- 21 sites in China
- Volunteers
- 265 people
- Sponsor
- GlaxoSmithKline
Edematous Fibrosclerotic Panniculopathy
Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP
This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP).
- Trial name
- NCT03675685
- Testing
- CCH (collagenase clostridium histolyticum)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Healthy
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3.
- Trial name
- NCT01468558
- Testing
- MAP0004, IV DHE, Ketoconazole
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allergan
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
Gastrointestinal Stromal Tumors
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients.
- Trial name
- NCT01396148
- Testing
- sunitinib malate dose escalation, sunitinib malate
- Where
- 9 sites in United States, Czechia and 1 more
- Volunteers
- 6 people
- Sponsor
- Pfizer
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Lymphoma, Advanced Solid Tumors
Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.
- Trial name
- NCT04144140
- Testing
- E7766
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Eisai Inc.
Advanced Solid Tumor
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose…
- Trial name
- MINOTAUR (NCT05147350)
- Testing
- RP-6306 (oral PKMYT1 inhibitor)
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 38 people
- Sponsor
- Debiopharm International SA
Non Small Cell Lung Cancer
Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior…
- Trial name
- NCT02317016
- Testing
- Pharmacokinetic sampling - AZD9291, AZD9291 tablet dosing, Rosuvastatin
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Myelodysplastic Syndromes
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes…
- Trial name
- NCT02240706
- Testing
- Best Supportive Care, BI 836858
- Where
- 5 sites in United States, Germany
- Volunteers
- 27 people
- Sponsor
- Boehringer Ingelheim
SARS-CoV-2, Influenza
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
- Trial name
- NCT05375838
- Testing
- mRNA-1073, mRNA-1010, mRNA-1273
- Where
- 14 sites in United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Gastrointestinal Motility Disorder
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy…
- Trial name
- NCT01644240
- Testing
- TD-8954
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Long Bone Delayed-Union Fracture
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone.
- Trial name
- NCT02020590
- Testing
- ALLOB® implantation
- Volunteers
- 25 people
- Sponsor
- Bone Therapeutics S.A
Breast Cancer
Post Market Study Using the Xoft Axxent System
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Trial name
- NCT01017549
- Testing
- Electronic brachytherapy (Axxent System)
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Xoft, Inc.
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Healthy Volunteers
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in…
- Trial name
- NCT03918239
- Testing
- SHP643
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Shire
Glioblastoma, MGMT-Unmethylated Glioblastoma
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase…
- Trial name
- NCT03250299
- Testing
- Microtubule-Targeted Agent BAL101553, Radiation Therapy
- Where
- 8 sites in United States
- Volunteers
- 26 people
- Sponsor
- Basilea Pharmaceutica
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