Clinical trials: Dose Escalation and Safety
Healthy Adult Subjects, Healthy Elderly Subjects
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118
- Trial name
- NCT02691702
- Testing
- BIIB118, Melatonin
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers
This is a randomized, placebo-controlled, single \& multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534.
- Trial name
- NCT02750553
- Testing
- SHR0534
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
This single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans.
- Trial name
- NCT02070939
- Testing
- PF-06260414
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Cancer, Metastatic Cancer
FS120 Phase 1/1b Study in Patients With Advanced Malignancies
This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies
- Trial name
- NCT04648202
- Testing
- FS120
- Where
- 9 sites in United States, Spain
- Volunteers
- 82 people
- Sponsor
- invoX Pharma Limited
Healthy Subject
A Study of ALS-4 in Healthy Adults Subjects
A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.
- Trial name
- NCT05274802
- Testing
- ALS-4
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aptorum International Limited
Genetic Disease, Nonsense Mutation
Phase 1 Study of ELX-02 in Healthy Adults
Phase 1 Single Ascending Dose Study in Normal Healthy Volunteers
- Trial name
- NCT03292302
- Testing
- ELX-02
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eloxx Pharmaceuticals, Inc.
Advanced Solid Tumor
TR64 in Patients With Advanced Solid Tumors
This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid…
- Trial name
- NCT05649345
- Testing
- TR64
- Where
- 2 sites in China
- Volunteers
- 19 people
- Sponsor
- Tarapeutics Science Inc.
Healthy Volunteers
Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast
This study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period.
- Trial name
- NCT02517372
- Testing
- CRD007
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- RSPR Pharma AB
Latent Tuberculosis, Latent Tuberculosis Bacteriology and Histology Unknown
Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at…
- Trial name
- NCT01967134
- Testing
- H56:IC31
- Where
- South Africa
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aeras
Hepatocellular Carcinoma
Safety and Efficacy of IPM001 in Patients With Advanced Hepatocellular Carcinoma
In this study, safety and effects of IPM001 injection on human hepatocellular carcinoma are going to be investigated, IPM001 is a multiple tumor-associated antigen (TAA) and neoantigen/tumor-specific antigen (TSA) sensitized…
- Trial name
- NCT05536427
- Testing
- IPM001
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Peking Union Medical College Hospital
Fever, Sweats, and Hot Flashes, Infection
Caspofungin Acetate in Treating Children With Fever and Neutropenia
RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation.
- Conditions
- Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer, Leukemia
- Trial name
- NCT00020527
- Testing
- caspofungin acetate
- Where
- 5 sites in United States
- Sponsor
- National Cancer Institute (NCI)
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts.
- Trial name
- NCT02712905
- Testing
- INCB059872, all-trans retinoic acid (ATRA), azacitidine
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 116 people
- Sponsor
- Incyte Corporation
Chronic Myeloid Leukemia
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.
- Trial name
- NCT02011945
- Testing
- Dasatinib, Nivolumab
- Where
- 21 sites in United States, Australia and 5 more
- Volunteers
- 35 people
- Sponsor
- Bristol-Myers Squibb
Colorectal Cancer, Pancreatic Ductal Cancer
A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
The primary objectives of Part 1 of this study are to: Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in participants with advanced or metastatic colorectal cancer (CRC) with a known mutation…
- Conditions
- Colorectal Cancer, Pancreatic Ductal Cancer, Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
- Trial name
- NCT06194877
- Testing
- BGB-3245, Panitumumab
- Where
- 5 sites in United States, Australia
- Volunteers
- 13 people
- Sponsor
- MapKure, LLC
Breast Cancer, Non Small Cell Lung Cancer
Study of ADCT-502 in Patients With Advanced Solid Tumors Withhuman Epidermal Growth Factor Receptor-2 (HER2) Expression
This study evaluated ADCT-502 in participants with Advanced Solid Tumors with HER2 Expression. Participants participated in a dose-escalation phase (Part 1) and were due to participate in the dose expansion phase (Part 2).
- Conditions
- Breast Cancer, Non Small Cell Lung Cancer, GastroEsophageal Cancer, Bladder Cancer
- Trial name
- NCT03125200
- Testing
- ADCT-502
- Where
- 5 sites in United States, Belgium
- Volunteers
- 21 people
- Sponsor
- ADC Therapeutics S.A.
Malignant Solid Tumor
A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors
An open-label, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and to evaluate the tolerance, the pharmacokinetic characteristics, the safety, and the efficacy of ScTIL210…
- Trial name
- NCT04571892
- Testing
- Super circulating tumor infiltrating lymphocytes(ScTIL)
- Where
- 2 sites in China
- Volunteers
- 58 people
- Sponsor
- Shanghai East Hospital
Hypertension
An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential hypertension.
- Trial name
- NCT00696436
- Testing
- Azilsartan medoxomil, Valsartan, Olmesartan
- Where
- 131 sites in United States, Argentina and 4 more
- Volunteers
- 1,291 people
- Sponsor
- Takeda
Malignancies
Study of PWT33597 Mesylate in Subjects With Advanced Malignancies
This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered PWT33597 mesylate in subjects with advanced malignancies.
- Trial name
- NCT01407380
- Testing
- PWT33597 mesylate
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pathway Therapeutics, Inc.
Diabetes Mellitus Type 2
A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin.
- Trial name
- NCT00460941
- Testing
- Taspoglutide 20mg, Taspoglutide 20mg-30mg, Taspoglutide 20mg-40mg
- Where
- 29 sites in United States, Australia and 5 more
- Volunteers
- 133 people
- Sponsor
- Hoffmann-La Roche
Advanced Relapsed Tumors, Refractory Solid Tumors
A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10
This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
- Trial name
- NCT02482441
- Testing
- OMP-131R10, FOLFIRI
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- OncoMed Pharmaceuticals, Inc.
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