Clinical trials: Dose Escalation and Safety
Surgical Site Infection
Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics
Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk patients receiving long segment…
- Trial name
- NCT01764750
- Testing
- Intrasite Vancomycin, IV Vancomycin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Advanced Solid Tumor, Non-small Cell Lung Cancer
A Study Evaluates the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients
The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593 alone in the treatment of advanced cancer.
- Trial name
- NCT03389815
- Testing
- WX-0593 Tablets
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
COVID-19 Pneumonia
Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia
This is a phase 2a, multicenter, randomized, double-blinded, placebo controlled, dose escalation study in adult subjects with COVID-19 pneumonia.
- Trial name
- NCT05205668
- Testing
- F-652
- Sponsor
- EVIVE Biotechnology
Solid Tumor
A Study Evaluating the Safety, Tolerability of LPM3480226 Tablets in Patients With Advanced Solid Tumors
This study is a non-randomized, open, multiple administration and dose escalation phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamics Characteristics of multiple oral administration of…
- Trial name
- NCT03844438
- Testing
- LPM3480226
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Luye Pharma Group Ltd.
Osteochondrodysplasia
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia
This is a Phase 2, open-label, multicenter, study to evaluate safety, tolerability and efficacy of SAR442501 in children from birth up to 12 years of age with Achondroplasia.
- Trial name
- upreACH-2 (NCT06067425)
- Testing
- SAR442501
- Where
- 9 sites in Australia, China and 3 more
- Volunteers
- 16 people
- Sponsor
- Sanofi
Epilepsy
A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects
The primary objective of this study is to evaluate the safety and tolerability of single ascending (increasing) and multiple doses of GWP42006 compared with placebo.
- Trial name
- NCT01918735
- Testing
- GWP42006
- Where
- United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Solid Tumors
AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours
The study will be an open label, multicenter, dose finding study. Depending on the tolerated dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54 depending on number of cohorts) may be…
- Trial name
- NCT00819221
- Testing
- AZD2281, liposomal doxorubicin
- Where
- 3 sites in Italy, Switzerland
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Developmental and Epileptic Encephalopathy, Dravet Syndrome
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.
- Conditions
- Developmental and Epileptic Encephalopathy, Dravet Syndrome, Lennox Gastaut Syndrome
- Trial name
- PACIFIC (NCT05364021)
- Testing
- LP352
- Where
- 34 sites in United States, Australia
- Volunteers
- 52 people
- Sponsor
- Longboard Pharmaceuticals
B-precursor Acute Lymphoblastic Leukemia, ALL
GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-084.
- Conditions
- B-precursor Acute Lymphoblastic Leukemia, ALL, GNR-084
- Trial name
- NCT04601584
- Testing
- Cohort 1, GNR-084, Cohort 2, GNR-084, Cohort 3, GNR-084
- Where
- 3 sites in Russia
- Volunteers
- 14 people
- Sponsor
- AO GENERIUM
Type 2 Diabetes Mellitus
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose…
- Trial name
- NCT00605475
- Testing
- Canakinumab, Metformin
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 231 people
- Sponsor
- Novartis
Cancer, Prostate Cancer
ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 and pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer.
- Trial name
- NCT02325557
- Testing
- ADXS31-142, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- Advaxis, Inc.
Heterozygous Familial Hypercholesterolemia, Premature Coronary Heart Disease
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease…
- Trial name
- NCT06164730
- Testing
- VERVE-102
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 85 people
- Sponsor
- Verve Therapeutics, Inc.
Crohn
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.
- Trial name
- ALLO-ASC (NCT01440699)
- Testing
- Allogenic human adipose-derived stem cells
- Where
- 3 sites in South Korea
- Volunteers
- 6 people
- Sponsor
- Anterogen Co., Ltd.
Amyotrophic Lateral Sclerosis (ALS)
A Study to Evaluate the Tolerability, Safety and Efficacy of VGN-R13 in Patients with ALS
The purpose of this trial is to evaluate safety and efficacy of intrathecal delivery of VGN-R13 as a treatment of Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- NCT06849609
- Testing
- VGN-R13
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Hong Chen
Chronic Graft-versus-host-disease
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
This is a Phase 1/2, Open-label, Dose Escalation study to investigate axatilimab in participants with active chronic graft versus host disease (cGVHD).
- Trial name
- NCT03604692
- Testing
- axatilimab
- Where
- 11 sites in United States
- Volunteers
- 41 people
- Sponsor
- Syndax Pharmaceuticals
Myeloid Malignancies, Acute Lymphocytic Leukemia
Safety and Clinical Activity of KT-253 in Adult Patients with High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid Tumors
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of KT-253 in adult patients with relapsed or refractory (R/R) high grade myeloid malignancies, acute…
- Conditions
- Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphomas, Advanced Solid Tumors
- Trial name
- NCT05775406
- Testing
- KT-253
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Kymera Therapeutics, Inc.
Neoplasms
An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma
This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent…
- Trial name
- Meteor 1 (NCT02783300)
- Testing
- GSK3326595, Pembrolizumab
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 297 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)
A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.
- Trial name
- NCT00943371
- Testing
- MK6349
- Volunteers
- 28 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Colorectal Carcinoma (mCRC), Colorectal Cancer (CRC)
Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
This trial will evaluate the safety, tolerability, and preliminary efficacy of tegavivint as monotherapy (single) and in combination with standard therapies in patients with metastatic colorectal carcinoma (mCRC).
- Conditions
- Metastatic Colorectal Carcinoma (mCRC), Colorectal Cancer (CRC), Adenomatous Polyposis Coli (APC) Gene Mutation, Catenin Beta-1 (CTNNB1) Gene Mutation
- Trial name
- NCT07463599
- Testing
- Tegavivint
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- HonorHealth Research Institute
Parkinson's Disease
Phase I, KM-819 in Healthy Subjects for Parkinson's Disease
This first in human, single-center, randomized, placebo-controlled, double blind, sequential group Phase 1 study in healthy subjects will be conducted to evaluate the safety, tolerability, PK, and PD following the escalation of…
- Trial name
- NCT03022799
- Testing
- KM-819
- Where
- South Korea
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Kainos Medicine Inc.
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