Clinical trials: Dose Escalation and Safety
Safety
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4.
- Trial name
- NCT03033329
- Testing
- Single intravenous doses of MRX-4, Multiple intravenous doses of MRX-4, Single dose of intravenous and oral MRX-4
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- MicuRx
Advanced Solid Tumors, Lymphoma
A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma.
- Trial name
- NCT00520637
- Testing
- EZN-2208
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- Enzon Pharmaceuticals, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS
This is a phase 1 study of investigational drug CFI-400945 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Relapsed Cancer, Refractory Cancer
- Trial name
- NCT03187288
- Testing
- CFI-400945 Fumarate
- Where
- 2 sites in Canada
- Volunteers
- 13 people
- Sponsor
- University Health Network, Toronto
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
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
Advanced Solid Tumor
A Study of QLS1209 in theTreatment of Patients With Advanced Solid Tumors
The goal of this clinical trial is to assess the safety and tolerability of QLS1209 alone in patients with eligible advanced solid tumors，determine the maximum tolerated dose (MTD) or maximum drug dose（MAD）of QLS1209, identify a…
- Trial name
- NCT06872580
- Testing
- QLS1209
- Volunteers
- 149 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Knee Osteoarthritis
A Trial to Evaluate the Safety, Tolerability, and Efficacy of NCR100 Injection in the Treatment of Subjects With KOA
This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It is a dose-escalating, open label study in adult KOA subjects.
- Trial name
- NCR100 (NCT06049342)
- Testing
- NCR100 injection
- Volunteers
- 12 people
- Sponsor
- Nuwacell Biotechnologies Co., Ltd.
Advanced Cancer, Solid Tumors
A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML
This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas.
- Conditions
- Advanced Cancer, Solid Tumors, Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse
- Trial name
- NCT03690154
- Testing
- FN-1501
- Where
- 3 sites in United States, Australia
- Volunteers
- 67 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Metastatic Castration-Resistant Prostate Cancer Patients, Castration-Resistant Prostate Cancer (CRPC)
YS247 (Neoantigen-Pulsed DC Vaccine) for Metastatic Prostate Cancer
This phase I study tests a personalized cancer vaccine (Neo-DC) for men with advanced prostate cancer (metastatic castration-resistant prostate cancer, or mCRPC) that has continued to grow despite standard hormone therapies and…
- Conditions
- Metastatic Castration-Resistant Prostate Cancer Patients, Castration-Resistant Prostate Cancer (CRPC), Prostate Neoplasms
- Trial name
- YS247 (NCT07583160)
- Testing
- Autologous Neoantigen-Pulsed Dendritic Cell Vaccine
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Changhai Hospital
Malaria
Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso
The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso.
- Trial name
- NCT01018459
- Testing
- Ad35.CS.01 Circumsporozoite Malaria Vaccine
- Where
- Burkina Faso
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
B-Cell Leukemia, B-Cell Lymphoma
A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies
It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+…
- Conditions
- B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors
- Trial name
- NCT05932173
- Testing
- Anti-CD19 Autologous CAR-T Cell Infusion
- Where
- China
- Volunteers
- 60 people
- Sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Infertility
Safety and Tolerability of TWP-201 in Healthy Female Subjects
This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection…
- Trial name
- NCT04878705
- Testing
- TWP-201
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.
Neuralgia
Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)
The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).
- Trial name
- NCT00592774
- Testing
- E2007 (perampanel)
- Where
- 47 sites in United States, Canada
- Volunteers
- 146 people
- Sponsor
- Eisai Inc.
Parkinson Disease
A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
- Trial name
- NCT06978920
- Testing
- Allogeneic dopaminergic neural precursor cell(NCR201)
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Nuwacell Biotechnologies Co., Ltd.
Alzheimer Disease
A Study of LY3002813 in Participants With Alzheimer's Disease
The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813.
- Trial name
- NCT01837641
- Testing
- LY3002813-IV, LY3002813-SC
- Where
- 6 sites in United States, Japan
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Advanced and/or Metastatic Solid Tumors Known to Express B7-H3
A Study of MX006 in Patients With Advanced and/or Metastatic Tumors Known to Express B7-H3
This is a Phase 1a/1b, multicenter, open-label, first-in-human (FIH) study with MX006 treatment in patients with selected tumor types known to express B7-H3.
- Trial name
- NCT07807241
- Testing
- MX006
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 120 people
- Sponsor
- Myricx Pharma Limited
Solid Tumor, Adult
A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study in adult subjects with advanced solid tumors for whom no standard therapy is available.
- Trial name
- NCT03355066
- Testing
- SM08502
- Where
- 19 sites in United States
- Volunteers
- 82 people
- Sponsor
- Biosplice Therapeutics, Inc.
Testicular Hypogonadism
Efficacy, Pharmacokinetics and Safety of Testosterone
This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.
- Trial name
- NCT01370369
- Testing
- Testosterone gel (FE 99903)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring Pharmaceuticals
Type 2 Diabetic Patients
A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients
This is a randomized, placebo-controlled, multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with dose of 5 mg, 10mg and 25 mg.
- Trial name
- NCT03006159
- Testing
- SHR0534
- Volunteers
- 36 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumors
A Trial of HTI-1090 in Subjects With Advanced Solid Tumors
IDO1 is expressed in a wide variety of human tumors (eg. bladder, breast, colon, DLBCL, HNSCC, lung, ovarian, uterine, renal…), and contributes to tumoral resistance.
- Trial name
- NCT03208959
- Testing
- HTI-1090
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Atridia Pty Ltd.
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