Clinical trials: Dose Escalation and Safety
Acute Coronary Syndrome
Study of LC23-1306 in Healthy Male Subjects
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics.
- Trial name
- NCT01526577
- Testing
- LC23-1306, Ticagrelor
- Where
- South Korea
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Solid Tumors
Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study.
- Trial name
- NCT03301896
- Testing
- LHC165, PDR001
- Where
- 9 sites in United States, Belgium and 5 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Acute Graft-versus-host Disease
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa in…
- Trial name
- NCT04539470
- Testing
- Efmarodocokin Alfa
- Where
- 8 sites in United States
- Volunteers
- 18 people
- Sponsor
- Genentech, Inc.
Metastatic Colorectal Cancer
Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer
The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil (5-FU)/folinic acid (FA) as first-line treatment for…
- Trial name
- NCT00422773
- Testing
- Cetuximab
- Where
- 3 sites in Germany
- Volunteers
- 21 people
- Sponsor
- Technische Universität Dresden
Infection, Human Immunodeficiency Virus
Single and Repeated Dose Escalation Study of GSK2838232
GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for the treatment of HIV in combination with other antiretroviral therapy (ART).
- Trial name
- NCT02795754
- Testing
- GSK2838232 PIB, GSK2838232 IR1, GSK2838232 IR2
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Covid19
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19
APN01 is a soluble recombinant form of the human angiotensin-converting enzyme 2 (rhACE2) that is currently under development as a therapy for corona-virus-disease 2019 (COVID-19).
- Trial name
- NCT05065645
- Testing
- Angiotensin Converting Enzyme 2, Sodium chloride
- Where
- Austria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Apeiron Biologics
Neoplasms, Lymphoma
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
This study is in 2 parts. The main aims of the 1st part of the study are to check if people with advanced solid tumors or cancers in the immune system (lymphomas) have side effects from TAK-981, and to check how much TAK-981 they…
- Conditions
- Neoplasms, Lymphoma, Hematologic Neoplasms
- Trial name
- NCT03648372
- Testing
- TAK-981
- Where
- 8 sites in United States
- Volunteers
- 109 people
- Sponsor
- Takeda
Crohns Disease
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
- Trial name
- NCT01769755
- Testing
- PDA001
- Where
- 12 sites in United States
- Volunteers
- 14 people
- Sponsor
- Celularity Incorporated
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
Solid Tumor, Adult, Advanced Solid Tumors
IMX-110 in Patients With Advanced Solid Tumors
Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110.
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumors, Pancreatic Cancer, Breast Cancer
- Trial name
- NCT03382340
- Testing
- Imx-110
- Where
- 2 sites in United States, Australia
- Volunteers
- 70 people
- Sponsor
- Immix Biopharma Australia Pty Ltd
Healthy
PAC-14028 in Healthy Male Volunteers
1. Primary Objective: To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers. 2.
- Trial name
- NCT01264224
- Testing
- PAC-14028
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Amorepacific Corporation
Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors
This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502…
- Conditions
- Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT05084859
- Testing
- SM08502, Abiraterone, Prednisone
- Where
- 20 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- Biosplice Therapeutics, Inc.
Patients w/Advanced Cancer That Failed Std of Care Therapy
A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin…
- Trial name
- NCT02138955
- Testing
- Liposomeal curcumin
- Where
- 2 sites in Austria
- Volunteers
- 30 people
- Sponsor
- SignPath Pharma, Inc.
Advanced Solid Tumors, Lymphoma
Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer.
- Trial name
- NCT00688415
- Testing
- VTX-2337
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- Celgene
Neoplasms, Advanced Solid Tumor
Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors
The main objectives of this study are to determine the safety profile of briciclib, an experimental anti-cancer drug, as it is administered intravenously once weekly as escalating doses in adult patients with advanced cancer and…
- Trial name
- NCT02168725
- Testing
- briciclib
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Traws Pharma, Inc.
Mucopolysaccharidosis Type II, Metabolic Diseases
A Multi-cohort Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers
It is a phase I open-label single-dose, dose-escalation cohort study to evaluate of the tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers
- Trial name
- NCT04539340
- Testing
- GNR-055
- Where
- Russia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Erectile Dysfunction
Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with…
- Trial name
- NCT01110590
- Testing
- BAY60-4552 + Vardenafil
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Bayer
High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML)
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled.
- Conditions
- High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML), AML - Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Trial name
- CROSSCHECK-001 (NCT06994676)
- Testing
- CBX-250
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- Crossbow Therapeutics, Inc.
Breast Cancer, Pancreatic Cancer
Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic…
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer, Carcinoma, Non-Small-Cell Lung
- Trial name
- NCT01761240
- Testing
- MORAb-066
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Morphotek
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