Clinical trials: Dose Escalation and Safety
Neoplasms
A Safety Study of Oral ZSTK474 in Patients With Cancer
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase (PI3K) inhibitor, in subjects with advanced…
- Trial name
- NCT01280487
- Testing
- ZSTK474
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- Zenyaku Kogyo Co., Ltd.
Herpes Zoster, Varicella Zoster
Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
The purpose of this clinical trial is to evaluate the safety, tolerability, and immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult subjects in the United States.
- Trial name
- NCT03820414
- Testing
- CRV 101
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Curevo Inc
Respiratory Syncytial Virus Infections
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose.
- Trial name
- NCT04444284
- Testing
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Investigational RSV vaccine MV-012-968 (Dosage 3)
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Meissa Vaccines, Inc.
Neurological Disorder
Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects
This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions).
- Trial name
- NCT05938452
- Testing
- Glyceryl Tribenzoate
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Forest Hills Lab
Hereditary Thrombotic Thrombocytopenic Purpura (TTP)
Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)
The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter, dose-escalation study is to evaluate the safety, including immunogenicity, and pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable…
- Trial name
- NCT02216084
- Testing
- Recombinant ADAMTS13
- Where
- 11 sites in United States, Austria and 5 more
- Volunteers
- 16 people
- Sponsor
- Baxalta now part of Shire
Neoplasms
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory…
- Trial name
- NCT01881217
- Testing
- BAY1179470
- Where
- 8 sites in Japan, Singapore and 1 more
- Volunteers
- 35 people
- Sponsor
- Bayer
Advanced Malignant Solid Tumors
A Study of CSCJC3456 in Patients With Advanced Malignant Tumors
This is a multicenter, open-label, phase I clinical study employing a dose-escalation and cohort-expansion design to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in…
- Trial name
- NCT06717750
- Testing
- CSCJC3456 tablet
- Where
- 2 sites in China
- Volunteers
- 102 people
- Sponsor
- Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.
Healthy Volunteers
A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.
- Trial name
- NCT01515358
- Testing
- LY3000328
- Where
- Singapore
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes
First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients
This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design.
- Trial name
- ODYSSEY (NCT05601726)
- Testing
- ABD-3001
- Where
- 3 sites in France
- Volunteers
- 36 people
- Sponsor
- Advanced BioDesign
Solid Tumor
Dose Escalation Trial of BNT152+153 in Patients With Cancer
This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications.
- Trial name
- NCT04710043
- Testing
- BNT152, BNT153
- Where
- 7 sites in United States, Czechia
- Volunteers
- 86 people
- Sponsor
- BioNTech SE
Advanced Cancer, Metastatic Cancer
Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors
This first-in-human open-label, dose escalation study is designed to evaluate the safety, tolerability, and PK of MRX-2843 in subjects with relapsed/refractory advanced and/or metastatic solid tumors.
- Conditions
- Advanced Cancer, Metastatic Cancer, Neoplasms, Neoplasm Metastasis
- Trial name
- NCT03510104
- Testing
- MRX-2843
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Meryx, Inc.
Relapsed or Refractory Classical Hodgkin Lymphoma
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
- Trial name
- NCT05216835
- Testing
- Sabestomig (AZD7789)
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Healthy Volunteers
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers
Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203…
- Trial name
- NCT02530710
- Testing
- Q203
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Qurient Co., Ltd.
Solid Tumor
A Study of HB002.1T Plus Chemotherapy in Subjects With Solid Tumor
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors.
- Trial name
- NCT04802980
- Testing
- HB002.1T, Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Huabo Biopharm Co., Ltd.
Type 2 Diabetes Mellitus
Safety Study of ISIS 325568 in Healthy Volunteers
The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.
- Trial name
- NCT00519727
- Testing
- ISIS 325568
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Healthy
Study of CM310 in Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
- Trial name
- NCT06161090
- Testing
- CM310
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Multiple Myeloma
A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Multiple myeloma (MM) is a neoplastic plasma cell disorder that is characterized by osteolytic bone lesions, anemia, hypercalcemia and renal failure.
- Trial name
- NCT04177823
- Testing
- Belantamab mafodotin
- Where
- China
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease
A Study of LY3113593 in Participants With Chronic Kidney Disease
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes…
- Trial name
- NCT02604160
- Testing
- LY3113593
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
- Trial name
- CYCAD-1 (NCT06188520)
- Testing
- AZD8421, Camizestrant, Ribociclib
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Pain
A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers
This is a two part study. The purpose of the first part is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following single escalating doses.
- Trial name
- NCT01259882
- Testing
- PF-05089771
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Pfizer
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