Clinical trials: Dose Escalation and Safety
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
Schizophrenia
Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
- Trial name
- NCT01738698
- Testing
- SPD489 40mg, SPD489 100mg, SPD489 160mg
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Shire
Healthy
A Study of ART105 in Healthy Adult Participants
The goal of this clinical trial is to learn if ART105 is safe in healthy adult participants. It will also learn about the PK and PD profiles of ART105.
- Trial name
- NCT07748026
- Testing
- ART105
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Arnatar Therapeutics, Inc.
Pulmonary Disease, Chronic Obstructive
BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
- Trial name
- NCT01958008
- Testing
- BI 113608 high dose b.i.d., BI 113608 low dose b.i.d.
- Where
- 6 sites in Germany
- Volunteers
- 84 people
- Sponsor
- Boehringer Ingelheim
Bone Metastases
Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors
JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL. In preclinical studies, JMT103 demonstrated strong activity through blocking RANKL receptor, RANK on the surface of osteoclasts, leading to inhibit…
- Trial name
- JMT103 (NCT03550508)
- Testing
- Anti-RANKL Monoclonal Antibody
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Shanghai JMT-Bio Inc.
Solid Tumor, Breast Cancer
Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies
The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors.
- Conditions
- Solid Tumor, Breast Cancer, Ovarian Cancer, Pancreatic Cancer
- Trial name
- NCT01041235
- Testing
- ATI-1123 (active drug = docetaxel)
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Azaya Therapeutics, Inc.
JNC 7 Stage 1 or 2 Hypertension
Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine
Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.
- Trial name
- NCT03635125
- Testing
- Nebivolol I, Nebivolol II, Baseline Washout Phase
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Trinity Hypertension & Metabolic Research Institute
Type 2 Diabetes
Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial
The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate…
- Trial name
- NCT06863532
- Testing
- Cofrogliptin+SGLT2i+Metformin, Metformin dose escalation
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
- Trial name
- NCT01597193
- Testing
- enzalutamide, anastrozole, exemestane
- Where
- 17 sites in United States
- Volunteers
- 101 people
- Sponsor
- Pfizer
Non-Hodgkin's Lymphoma
Safety and Efficacy of Iodine-131 Anti-B1 Antibody for NHL Patients With Greater Than 25% Bone Marrow Involvement
The purpose of this study is to determine the proper dose, effectiveness, and safety of using Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated non-Hodgkin's lymphoma (NHL) who have greater than…
- Trial name
- NCT00022906
- Testing
- Iodine-131 Anti-B1 Antibody
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Corixa Corporation
Advanced Solid Tumours
A Study of Subcutaneous FL115 Monotherapy in Participants With Advanced Solid Tumors
This is an open-label, multicenter, dose-escalation Phase Ib clinical study to evaluate the safety, tolerability, efficacy, PK, and PD of FL115 injection administered subcutaneously as monotherapy in participants with advanced…
- Trial name
- NCT07785193
- Testing
- FL115
- Where
- Australia
- Volunteers
- 29 people
- Sponsor
- Suzhou Forlong Biotechnology Co., Ltd
Neoplasms, Pancreatic Neoplasms
Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
- Trial name
- NCT00102752
- Testing
- Glufosfamide, Gemcitabine
- Where
- 9 sites in United States, Brazil
- Volunteers
- 47 people
- Sponsor
- Threshold Pharmaceuticals
Hepatocellular Carcinoma, Liver Cancer
Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma
This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte…
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer
- Trial name
- ET-109 (NCT03998033)
- Testing
- ET140202 autologous T cell product
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Eureka Therapeutics Inc.
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or…
- Trial name
- NCT06433947
- Testing
- OPN-6602, Dexamethasone
- Where
- 12 sites in United States
- Volunteers
- 130 people
- Sponsor
- Opna Bio LLC
Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma
Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma
This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD)…
- Trial name
- NCT04984434
- Testing
- F182112
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Solid Tumor, Adult
A Study of of HOT1030 in Patients With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors
- Trial name
- NCT05060263
- Testing
- HOT-1030
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Huabo Biopharm Co., Ltd.
Healthy Participants
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
- Trial name
- NCT05604287
- Testing
- ID119031166M
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Actinic Keratosis
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
- Trial name
- NCT00659893
- Testing
- PEP005 Topical gel
- Where
- 13 sites in United States, Australia
- Volunteers
- 64 people
- Sponsor
- Peplin
Usher Syndrome, Type 1B
Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
The purpose of the 081-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-081 in USH1B patients with retinitis pigmentosa due to a mutation in the MYO7A gene.
- Trial name
- NCT06591793
- Testing
- AAVB-081
- Where
- 3 sites in Italy, United Kingdom
- Volunteers
- 15 people
- Sponsor
- AAVantgarde Bio Srl
Healthy Volunteers
Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers
The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-201, in healthy volunteers.
- Trial name
- NCT02603224
- Testing
- MRG-201
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- miRagen Therapeutics, Inc.
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