Clinical trials: Dose Escalation and Safety
Chikungunya
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization.
- Trial name
- NCT03382964
- Testing
- VLA1553
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Rhinitis, Allergic, Seasonal
Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy Male Subjects
This is a double-blind, placebo-controlled, randomized single dose escalation study and a double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose study to investigate safety, tolerability and…
- Trial name
- NCT00694993
- Testing
- GSK1004723
- Where
- Germany
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rett Syndrome
A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the…
- Trial name
- NCT05606614
- Testing
- TSHA-102
- Where
- 9 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Taysha Gene Therapies, Inc.
Neoplasm Malignant
Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients
Primary Objective: In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844. In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene…
- Trial name
- SARMETA (NCT01657214)
- Testing
- SAR125844
- Where
- 8 sites in Japan, South Korea
- Volunteers
- 70 people
- Sponsor
- Sanofi
Advanced Solid Tumors, Metastatic Solid Tumors
Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
This is a first-in-human, Phase I, multicenter, open-label, dose escalation study with dose expansion to evaluate the safety and antitumor activity of ODC-IL2 in patients with advanced or metastatic solid tumors.
- Trial name
- NCT06770764
- Testing
- ODC-IL2
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Trutino Biosciences Inc.
Advanced Solid Malignancies
Open Label, Dose Escalation Phase I Study of AZD2281
The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies
- Trial name
- NCT00572364
- Testing
- KU-0059436 (AZD2281)(PARP inhibitor)
- Where
- Japan
- Volunteers
- 18 people
- Sponsor
- AstraZeneca
Myelodysplastic Syndromes, Myeloproliferative Disorders
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the plasma concentration time curve (AUC).
- Conditions
- Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Lymphocytic, Myeloma
- Trial name
- NCT00361140
- Testing
- Busulfan, Fludarabine
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Healthy Participants
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants.
- Trial name
- NCT06213818
- Testing
- INCB160058, Esomeprazole, Famotidine
- Where
- Australia
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Safety and Tolerability of EGT0001474 in Healthy Volunteers
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
- Trial name
- NCT00854113
- Testing
- EGT0001474
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Theracos
Cancer-Neoplasms
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab.
- Trial name
- NCT06537310
- Testing
- RO7567132 and Atezolizumab
- Where
- 11 sites in Australia, Belgium and 3 more
- Volunteers
- 34 people
- Sponsor
- Hoffmann-La Roche
Metastatic Cancer, Cancer
BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors
This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as…
- Conditions
- Metastatic Cancer, Cancer, Solid Tumor
- Trial name
- NCT01957735
- Testing
- BP31510 monotherapy, BP31510 in combination with chemotherapy
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- BPGbio
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
Dyslipidemia
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519.
- Trial name
- CKD-519 FIH (NCT02156544)
- Testing
- CKD-519
- Where
- South Korea
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Pediatric Solid Tumor, Pediatric Lymphoma
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment…
- Conditions
- Pediatric Solid Tumor, Pediatric Lymphoma, Pediatric Brain Tumor, DIPG
- Trial name
- CLOVER-2 (NCT03478462)
- Testing
- CLR 131
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 30 people
- Sponsor
- Cellectar Biosciences, Inc.
Non-small Cell Lung Cancer
Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer
This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial…
- Trial name
- NCT05171062
- Testing
- bexmarilimab (FP-1305), Pembrolizumab
- Where
- United States
- Sponsor
- The University of Texas Health Science Center at San Antonio
Inflammation, Rheumatoid Arthritis
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single…
- Trial name
- NCT00927927
- Testing
- NNC0142-0002
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Janssen Research & Development, LLC
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Phase I/IIa, Open-label, Single-center, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IMV101 as a Single Agent in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A phase I/IIa, open-label, single-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and preliminary efficacy of IMV101 as a single agent in subjects with relapsed/refractory B-cell non-Hodgkin…
- Trial name
- NCT07376642
- Testing
- IMV101 treatment
- Where
- 4 sites in China
- Volunteers
- 30 people
- Sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
Advanced Solid Tumors
A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
This clinical trial is an open-label, single-arm, non-randomized, dose-escalation and dose-expansion study targeting subjects with unresectable, advanced, malignant solid tumors who have failed or are unsuitable for standard…
- Trial name
- NCT07222969
- Testing
- VIB305 for Injection
- Where
- 2 sites in Australia, China
- Volunteers
- 146 people
- Sponsor
- Vibrant Sciences Limited
Median Sternotomy
Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery.
- Trial name
- NCT01657045
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- SironRX Therapeutics, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with…
- Trial name
- NCT06146257
- Testing
- GLB-001
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- GluBio Therapeutics Inc.
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