Clinical trials: Dose Escalation and Safety
Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or…
- Trial name
- NCT02457793
- Testing
- Cobimetinib, GDC-0994
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Huntington Disease
Safety and Tolerability Study With VY-HTT01, in Adults With Early Manifesting Huntington's Disease
This is the first clinical study of VY-HTT01, a gene therapy for early-stage Huntington's Disease (HD) patients. The primary goal of this trial is to evaluate the safety and tolerability of VY-HTT01.
- Trial name
- NCT04885114
- Testing
- Intraparenchymal rAAV1 - (mi)RNA HTT
- Sponsor
- Voyager Therapeutics
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blasts 5 Percent or More of Bone Marrow Nucleated Cells
EphB4-HSA Fusion Protein and Cytarabine /or Liposomal Vincristine in Patients With Recurrent or Refractory Acute Leukemia
This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein when given together with cytarabine or vincristine liposomal in treating participants with acute leukemia that has come back or has…
- Conditions
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blasts 5 Percent or More of Bone Marrow Nucleated Cells, Myelodysplastic/Myeloproliferative Neoplasm, Philadelphia Chromosome Positive
- Trial name
- NCT03519984
- Testing
- Cytarabine, Laboratory Biomarker Analysis, Recombinant EphB4-HSA Fusion Protein
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Southern California
X-linked Retinoschisis
Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103…
- Trial name
- NCT05814952
- Testing
- LX103 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
HIV-1-infection
Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants
This study will evaluate the safety and behavior in the body of the experimental drug TMB-365 in people with HIV-1 infection. This will be the first test of TMB-365 in humans.
- Trial name
- NCT04027387
- Testing
- TMB-365
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- TaiMed Biologics Inc.
Solid Tumor, Renal Cell Carcinoma (Kidney Cancer)
A Study of NDI 1150-101 in Patients With Solid Tumors
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as…
- Conditions
- Solid Tumor, Renal Cell Carcinoma (Kidney Cancer), Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Non-Small Cell Lung Cancer
- Trial name
- NCT05128487
- Testing
- NDI-101150, Pembrolizumab
- Where
- 19 sites in United States
- Volunteers
- 106 people
- Sponsor
- Nimbus Saturn, Inc.
Pancreatic Cancer
Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
- Trial name
- NCT01446952
- Testing
- Vitamin E δ-Tocotrienol
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Choroidal Neovascularization, Diabetic Retinopathy
PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate.
- Conditions
- Choroidal Neovascularization, Diabetic Retinopathy, Diabetic Macular Edema
- Trial name
- MATISSE (NCT01445899)
- Testing
- PF-04523655 (Stratum I), ranibizumab, PF-04523655 (Stratum II)
- Where
- 51 sites in United States, Belgium and 5 more
- Volunteers
- 258 people
- Sponsor
- Quark Pharmaceuticals
Lumbar Vertebra Hernia
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
- Trial name
- NCT01282606
- Testing
- SI-6603
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Seikagaku Corporation
Healthy Participants, Hemophilia A
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604…
- Conditions
- Healthy Participants, Hemophilia A, Hemophilia B, Factor VII Deficiency
- Trial name
- NCT06349473
- Testing
- SR604
- Where
- 10 sites in United States, Canada
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Equilibra Bioscience LLC
Healthy Volunteers
Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.
- Trial name
- NCT04715529
- Testing
- FZJ-003
- Where
- China
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Solid Cancers, BRCA Mutation
A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway
The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss of function…
- Conditions
- Solid Cancers, BRCA Mutation, HRD Cancer, Breast Cancer
- Trial name
- NCT06614751
- Testing
- DAT-2645 tablet
- Where
- 2 sites in China
- Volunteers
- 112 people
- Sponsor
- Danatlas Pharmaceuticals Co., Ltd
EBV
mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
This is a Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
- Trial name
- NCT07557602
- Testing
- VXCO-102
- Where
- 2 sites in Australia
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company
Optic Atrophy, Non-arteritic Anterior Ischemic Optic Neuropathy
Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (QPI-1007) will be given to all patients who participate.
- Trial name
- NCT01064505
- Testing
- QPI-1007 at various doses
- Where
- 28 sites in United States, Israel
- Volunteers
- 48 people
- Sponsor
- Quark Pharmaceuticals
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
A Phase I of SS109 in Hemophilia A or and B With Inhibitors
This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to…
- Conditions
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Factor VII Deficiency
- Trial name
- NCT05651061
- Testing
- SS109
- Where
- 10 sites in China
- Volunteers
- 27 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Alzheimer' s Disease
A Clinical Trial of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease.
- Trial name
- NCT07301502
- Testing
- AK152
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Akeso
Locally Advanced Solid Tumor, Metastatic Solid Tumor
HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors
This study evaluates the safety, tolerability and pharmacokinetics of HM95573 In combination with either cobimetinib or cetuximab in patients with locally advanced or metastatic solid tumors.
- Trial name
- NCT03284502
- Testing
- HM95573, cobimetinib, HM95573, cetuximab
- Where
- 9 sites in South Korea
- Volunteers
- 148 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Traumatic Brain Injury
A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.
A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V.
- Trial name
- NCT00735085
- Testing
- SLV334
- Where
- 14 sites in United States, Israel and 2 more
- Volunteers
- 57 people
- Sponsor
- Abbott Products
Advanced Solid Tumours
A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors.
This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811 at increasing doses in patients with advanced solid tumours and for whom no standard of care exists.
- Trial name
- NCT02579226
- Testing
- AZD2811
- Where
- 6 sites in United States
- Volunteers
- 72 people
- Sponsor
- AstraZeneca
Hypercholesterolemia, Familial
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT00281008
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 44 people
- Sponsor
- Kastle Therapeutics, LLC
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