Clinical trials: Dose Escalation and Safety
Healthy Volunteers
Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects
This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
- Trial name
- NCT04464681
- Testing
- M201-A Injection
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Kitasato University
Healthy Volunteers
Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045
Phase I, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD), study to evaluate the safety/tolerability and pharmacokinetics (PK) of FP-045 administered to normal health volunteers (NHVs).
- Trial name
- NCT03686930
- Testing
- Cohort 1 - FP-045 oral solution, Cohort 2 - FP-045 oral solution, Cohort 3 - FP-045 oral solution
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Neoplasms
A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors
This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic…
- Trial name
- NCT02410512
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody, MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 610 people
- Sponsor
- Genentech, Inc.
Non Small Cell Lung Cancer
Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer
This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.
- Trial name
- NCT05705466
- Testing
- Navtemadlin, Pembrolizumab
- Sponsor
- Kartos Therapeutics, Inc.
Advanced Solid Tumor, B Cell Lymphoma
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1
This study is the first-in-human clinical trial of CN1 to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of CN1 in patients with advanced solid tumors or B-cell lymphoma.
- Trial name
- NCT04418141
- Testing
- CN1
- Where
- Austria
- Volunteers
- 13 people
- Sponsor
- Curon Biopharmaceutical (Australia) Co Pty Ltd
Cancer
NUC-1031 in Patients With Advanced Solid Tumours
This is a two-part Phase I, open label, dose-escalation, study of NUC-1031 as a single agent in patients with advanced solid tumours who have failed to respond to or who have relapsed after treatment with standard therapy.
- Trial name
- ProGem1 (NCT01621854)
- Testing
- NUC-1031
- Where
- United Kingdom
- Volunteers
- 68 people
- Sponsor
- Imperial College London
Hypertriglyceridemia
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in hypertriglyceridemic subjects.
- Trial name
- NCT00435045
- Testing
- Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin, atorvastatin
- Volunteers
- 245 people
- Sponsor
- GlaxoSmithKline
Tuberculosis
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential.
- Trial name
- C-010-402 (NCT02414828)
- Testing
- AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp, AERAS-402 3 x 10^10 vp
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aeras
Advanced Solid Tumor, Adult Disease
A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients with Advanced Cancer.
The purpose of this study is to test the safety and efficacy of ANV419 (single agent) and in combination with ipilimumab in patients with relapsed/refractory advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Adult Disease, Lung Cancer
- Trial name
- ANV419-001 (NCT04855929)
- Testing
- ANV419, Ipilimumab
- Where
- 5 sites in Spain, Switzerland and 1 more
- Volunteers
- 55 people
- Sponsor
- Anaveon AG
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Locally Advanced or Metastatic Solid Tumors
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
- Trial name
- BC3195 (NCT05957471)
- Testing
- Drug: BC3195 for Injection
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Biocity Biopharmaceutics Co., Ltd.
Healthy Adult
Study of SON-1010 (IL12-FHAB) in Healthy Adults
SB102 is a randomized, double-blind, single center, placebo-controlled study in healthy adults starting with sentinel participants at each dose level to carefully assess the safety, tolerability, PK, and PD of SON-1010.
- Trial name
- NCT05408572
- Testing
- SON-1010 (IL12-FHAB)
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sonnet BioTherapeutics
Contrast Induced Nephropathy
Safety Study Of N-Acetylcysteine For Prevention Of Contrast Induced Nephropathy In Patients w/Stage 3 Renal Failure
This will be a randomized prospective dose escalation clinical study of N-acetylcysteine (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60 ml/min calculated with the Modification of Diet in…
- Trial name
- CIN-NAC (NCT00575419)
- Testing
- N-acetylcysteine
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Oregon Health and Science University
Myocardial Infarction
Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular…
- Trial name
- NCT00555828
- Testing
- Allogeneic Mesenchymal Precursor Cells (MPCs), Standard-of-care treatment with NOGA® mapping and staged injections.
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Angioblast Systems
Chronic Spontaneous Urticaria
Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.
- Trial name
- BEACON (NCT06162728)
- Testing
- Briquilimab
- Where
- 23 sites in United States, Germany
- Volunteers
- 87 people
- Sponsor
- Jasper Therapeutics, Inc.
Cancer, Neoplasms
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma
This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion.
- Trial name
- NCT02082977
- Testing
- GSK2816126
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Healthy
Safety and Tolerability Study of Multiple Doses of PF-06305591
Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.
- Trial name
- NCT01776619
- Testing
- PF-06305591
- Where
- Belgium
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Pfizer
Gout
The the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XNW3009 in Health Subject
XNW3009 is a small molecule hURAT1 inhibitor developed independently by Sinovent Pty Ltd., and is intended to treat gout-related hyperuricemia.
- Trial name
- NCT04040907
- Testing
- XNW3009
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Evopoint Biosciences Inc.
Advanced Solid Tumor
Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor
Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes.
- Trial name
- NCT05103345
- Testing
- SGN1
- Where
- 4 sites in China, Taiwan
- Volunteers
- 70 people
- Sponsor
- Guangzhou Sinogen Pharmaceutical Co., Ltd
Healthy Volunteers
Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population
This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria for at least 4 months. The study will take place in parts of Africa where malaria is common.
- Trial name
- NCT06408857
- Testing
- MAM01 300 mg SC, MAM01 300 mg IM, MAM01 2000 mg IV
- Where
- 2 sites in Uganda
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.