Clinical trials: Phase I
Osteoarthritis
A Phase I, Prospective, Randomized, Open-label, Active-Controlled Clinical Trial for Safety Evaluation of Intra-articular Injection of RegenoGel-SP for the Treatment of Moderate to Severe Osteoarthritis
This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial designed to assess the safety and tolerability of single intra-articular injection of RegenoGel-SP for the treatment of OA.
- Trial name
- NCT02188771
- Testing
- intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)
- Where
- Israel
- Volunteers
- 11 people
- Sponsor
- ProCore Ltd.
Healthy
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of HHT120 in Healthy Subjects
This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy…
- Trial name
- HHT120 (NCT05414734)
- Testing
- HHT120
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Advanced Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
This phase I trial investigates the side effects and best dose of talazoparib when given together with trifluridine/tipiracil for the treatment of patients with colorectal or gastroesophageal cancer that has spread to nearby…
- Conditions
- Advanced Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT04511039
- Testing
- Trifluridine and Tipiracil Hydrochloride, Talazoparib Tosylate
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Roswell Park Cancer Institute
Rheumatoid Arthritis (RA)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX).
- Trial name
- NCT02698657
- Testing
- ASP5094
- Where
- 13 sites in United States, Poland
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Resectable Intrahepatic Cholangiocarcinoma, Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8
Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial
This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with…
- Conditions
- Resectable Intrahepatic Cholangiocarcinoma, Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8, Stage I Intrahepatic Cholangiocarcinoma AJCC v8, Stage II Intrahepatic Cholangiocarcinoma AJCC v8
- Trial name
- NCT05514912
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Infigratinib Phosphate
- Sponsor
- Emory University
Healthy Volunteers
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
- Trial name
- RaniPill (NCT03798912)
- Testing
- RaniPill capsule containing octreotide
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- RANI Therapeutics
Haematological Malignancies
Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction…
- Trial name
- NCT04865419
- Testing
- AZD0466, Voriconazole
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 46 people
- Sponsor
- AstraZeneca
Bone Marrow Failure Syndrome, Thalassemia
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum…
- Conditions
- Bone Marrow Failure Syndrome, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia
- Trial name
- NCT03513328
- Testing
- Thiotepa--single daily dose, Thiotepa--escalated dose
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Florida
Lower Respiratory Tract Disease, Healthy Participants
Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults
This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults.
- Trial name
- VXB251-001 (NCT07295028)
- Testing
- trivalent (RSV/hMPV/PIV3) vaccine candidate, bivalent (RSV/hMPV) unlicensed comparator, monovalent (RSV) unlicensed comparator
- Where
- 6 sites in Australia
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy, Safety
AZD2624 Multiple Ascending Dose Study in Japan
This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624
- Trial name
- JMAD (NCT00696865)
- Testing
- AZD2624
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bipolar Disorder Type I With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
- Trial name
- NCT06951711
- Testing
- KarXT
- Where
- 85 sites in United States, China and 9 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma
Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and dasatinib when given together with erlotinib hydrochloride in treating patients with pancreatic cancer that has spread to other places in…
- Conditions
- Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7
- Trial name
- NCT01660971
- Testing
- Dasatinib, Erlotinib Hydrochloride, Gemcitabine Hydrochloride
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy…
- Trial name
- NCT00002627
- Testing
- filgrastim, carboplatin, cyclophosphamide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- St. Louis University
Subarachnoid Hemorrhage, Aneurysmal
Induced Suppression of Platelets Activity in Aneurysmal SAH Management (iSPASM)
This is a phase 1/2a, randomized, double blind, single-center study comparing standard care alone to standard care with Aggrastat in patients diagnosed with aneurysmal subarachnoid hemorrhage.
- Trial name
- NCT03691727
- Testing
- tirofiban hydrochloride (AGGRASTAT®), MRI, Neurological Exam
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- David Hasan
Healthy Subjects, Obesity
A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects
This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy…
- Conditions
- Healthy Subjects, Obesity, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT05943886
- Testing
- HEC88473 injection
- Where
- China
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Rheumatoid Arthritis
A Study of Single and Multiple Oral Doses of TollB-001
The primary objective is to evaluate the safety and tolerability of TollB-001 following the administration of single or multiple oral doses in healthy adult subjects
- Trial name
- NCT06103773
- Testing
- TollB-001 tablets
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Toll Biotech Co. Ltd. (Beijing)
Alzheimer's Disease (AD)
Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's Patients
This study is testing a new investigational drug called 8M2D to learn whether it is safe and well-tolerated in humans. 8M2D has not previously been given to people.
- Trial name
- NCT07568041
- Testing
- 8M2D
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Cenna Biosciences Inc.
Primary Biliary Cholangitis
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices…
- Trial name
- NCT05624294
- Testing
- CS0159
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
B Cell Malignancies
A Phase 1/2 Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor (SHB-04-CD22) in Patients With CD22-expressing B-cell Malignancies
This is a phase I/II trial of T-cell expressing an anti-CD22 Chimeric-Antigen-Receptor (CAR) in patients with CD22 expressing B-cell malignancies.
- Trial name
- NCT07135466
- Testing
- CD22 CAR-T cells
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Sheba Medical Center
CYP3A Inhibitor, Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma
To explore the possibility to overcome CYP3A-mediated resistance to anticancer drugs in pancreatic cancer, we will investigate the pharmacokinetics, safety, tolerability, and efficacy of nanoparticle albumin-bound paclitaxel…
- Conditions
- CYP3A Inhibitor, Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreatic Adenocarcinoma
- Trial name
- IntenSify (NCT05494866)
- Testing
- Cobicistat Oral Tablet, Gemcitabin, Nab paclitaxel
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- German Cancer Research Center
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