Clinical trials: Dose Escalation and Safety
Cancer, Advanced Solid Malignancies
Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects
The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.
- Trial name
- NCT01340040
- Testing
- MEDI-573
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Obesity
A Study of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Participants and a Study of JNJ-6456511 in Otherwise Healthy Obese Adult Participants After Multiple Dose
The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC administrations in the thigh versus the abdomen in…
- Trial name
- NCT03586843
- Testing
- JNJ-64565111
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy…
- Trial name
- NCT00812825
- Testing
- PF-04171327, Prednisolone, PF-04171327 Tablet
- Where
- Belgium
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Solid Tumor, NSCLC
A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.
- Trial name
- MICA (NCT05117476)
- Testing
- CLN-619, Pembrolizumab, Paclitaxel
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 440 people
- Sponsor
- Cullinan Therapeutics Inc.
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
Leukemia, Hairy Cell Leukemia
Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded to chemotherapy, surgery or radiation…
- Conditions
- Leukemia, Hairy Cell Leukemia, HCL
- Trial name
- NCT00462189
- Testing
- Immunotoxin therapy, CAT-8015 Immunotoxin, Biological therapy
- Where
- 5 sites in United States, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Cambridge Antibody Technology
Healthy
A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers
The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.
- Trial name
- NCT02333318
- Testing
- VVZ-149 injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vivozon, Inc.
Diabetic Macular Edema
Gene Therapy for Diabetic Macular Edema
FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic…
- Trial name
- NCT05916391
- Testing
- FT-003
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Frontera Therapeutics
Gastric Cancer, Bladder Cancer
Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies.
- Conditions
- Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer, Cholangiocarcinoma
- Trial name
- NCT04149691
- Testing
- CPL304110
- Where
- 7 sites in Poland
- Volunteers
- 37 people
- Sponsor
- Celon Pharma SA
Syndrome of Inappropriate ADH (SIADH) Secretion, Hyponatremia
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate…
- Trial name
- NCT00032734
- Testing
- satavaptan (SR121463B)
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 35 people
- Sponsor
- Sanofi
Non-Small-Cell Lung Cancer
Safety Study of XL999 in Adults With Non-Small-Cell Lung Cancer
The purpose of this study is to determine the safest dose of XL999 and how well subjects with Non-Small-Cell Lung Cancer tolerate XL999.
- Trial name
- NCT00491699
- Testing
- XL999
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Symphony Evolution, Inc.
Healthy
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
- Trial name
- NCT00822341
- Testing
- TG-0054
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GPCR Therapeutics, Inc.
Advanced Cancer
Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK inhibitor, in advanced cancer patients. Secondary Objectives: To describe the initial PK of different doses of RDEA119 when given once orally on…
- Trial name
- NCT00610194
- Testing
- RDEA119
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- Bayer
Solid Tumor
Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer). Main questions: What does the study drug do to human body (Pharmacodynamics [='PD']) What does the body do to study drug (how processed in…
- Trial name
- NCT06086522
- Testing
- QN-302
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- Qualigen Theraputics, Inc.
Solid Tumor
Phase 1 Study of HLX10, a Monoclonal Antibody Targeting Programmed Death-1 (PD-1) in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of humanized anti-PD-1 monoclonal antibody, HLX10, in patients with advanced or metastatic tumors refractory to…
- Trial name
- NCT03468751
- Testing
- HLX10
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Henlix, Inc
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth…
- Trial name
- NCT01563445
- Testing
- activated recombinant human factor VII
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Hypertension
Efficacy and Safety of Moxonidine in Indian Patients
The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.
- Trial name
- NCT00160277
- Testing
- Moxonidine
- Where
- 3 sites in India
- Volunteers
- 100 people
- Sponsor
- Solvay Pharmaceuticals
Advanced / Metastatic Solid Tumor
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint…
- Trial name
- NCT06063681
- Testing
- SR-8541A, Immune checkpoint inhibitor (ICI)
- Where
- 3 sites in Australia
- Volunteers
- 25 people
- Sponsor
- Stingray Therapeutics
Solid Cancers
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.
- Trial name
- NCT00977067
- Testing
- GDC-0152
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Healthy Adult Subjects
ONO-7746 Study in Healthy Adult Subjects
The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.
- Trial name
- NCT00956371
- Testing
- ONO-7746
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
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