Clinical trials: Dose Escalation and Safety
Healthy
Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers
This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.
- Trial name
- NCT02238834
- Testing
- FP-025
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Non-Hodgkin's Lymphoma, Hodgkin Lymphoma
Safety Study of Anti-Programmed Death-Ligand 1 in Hematologic Malignancy
The purpose of this study is to determine the side effects of treatment with the monoclonal antibody anti-PD-L1 (BMS-936559) in subjects with compromised bone marrow function and the dose that should be recommended for use in…
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma, Chronic Myelogenous Leukemia
- Trial name
- NCT01452334
- Testing
- BMS-936559 (Anti PD-L1)
- Sponsor
- Bristol-Myers Squibb
Advanced Solid Tumors, Lymphoma
KN046 in Subjects With Advanced Solid Tumors and Lymphoma
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
- Trial name
- NCT03733951
- Testing
- KN046
- Where
- 13 sites in China
- Volunteers
- 139 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Type 2 Diabetes Mellitus
FTIH of ECC5004 in Healthy and Diabetic Participants
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants and in patients with Type 2 Diabetes Mellitus
- Trial name
- NCT05654831
- Testing
- ECC5004
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Eccogene
Alzheimer's Disease
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.
- Trial name
- NCT00455000
- Testing
- PF-04360365
- Where
- 12 sites in Australia, Canada and 2 more
- Volunteers
- 37 people
- Sponsor
- Pfizer
Metabolism and Nutrition Disorder, Obesity
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with…
- Trial name
- NCT03015207
- Testing
- NNC0194-0499
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Novo Nordisk A/S
Healthy
A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers
This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days…
- Trial name
- NCT02066909
- Testing
- 0.15 mg PF-06649751, 0.5 mg PF-06649751, 1.5 mg PF-06649751
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Cancer
Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK105 as a single agent in adult subjects with advanced solid tumor malignancies.
- Trial name
- NCT03352531
- Testing
- AK-105
- Where
- 5 sites in Australia
- Volunteers
- 99 people
- Sponsor
- Akesobio Australia Pty Ltd
CNS Lymphoma
[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the treatment of recurrent or refractory primary…
- Trial name
- NCT06132737
- Testing
- [90Y]Y-PentixaTher
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Pentixapharm AG
Food Allergy
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy.
- Trial name
- NCT06369467
- Testing
- linvoseltamab, dupilumab
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- Regeneron Pharmaceuticals
Multiple Myeloma
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation…
- Trial name
- NCT03828292
- Testing
- Belantamab mafodotin, Bortezomib, Dexamethasone
- Where
- 4 sites in Japan
- Volunteers
- 15 people
- Sponsor
- GlaxoSmithKline
Relapsed/Refractory, Multiple Myeloma
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone…
- Trial name
- NCT03439280
- Testing
- Mezagitamab, Pomalidomide, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Thrombocytopenia
A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID).
- Trial name
- NCT06521931
- Testing
- PN20
- Where
- 6 sites in China
- Volunteers
- 24 people
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
H1N1 Flu
Study of the Safety and Immunogenicity of H1N1 Vaccine
The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults
- Trial name
- NCT01177202
- Testing
- HAC1 Vaccine
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
Cancer
A Study to Assess the Safety and Efficacy of UNO - Ultra High Concentration Nitric Oxide Injection in Combination With PD-1 Inhibitors Into Unresectable Solid Primary or Metastatic Tumors
This is a Phase 1, open-label, dose-escalation and dose-expansion study comprised of 2 parts: Phase 1a - a single treatment session, an evaluation period of 21±3 days, and safety and survival follow-up period of up to 12 weeks…
- Trial name
- NCT05351502
- Testing
- Nitric Oxide 25,000 ppm, Nitric Oxide 50,000 ppm
- Where
- 4 sites in Israel
- Volunteers
- 38 people
- Sponsor
- Beyond Air Inc.
Anthrax
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Primary: To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 To evaluate…
- Trial name
- NCT01202695
- Testing
- AVP-21D9
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Neoplasms
A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors
This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in participants with locally advanced or…
- Trial name
- NCT02219724
- Testing
- MOXR0916
- Where
- 31 sites in United States, Australia and 4 more
- Volunteers
- 174 people
- Sponsor
- Genentech, Inc.
Malaria
Trial to Evaluate L9LS in Healthy Adults
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly.
- Trial name
- VRC 614 (NCT05019729)
- Testing
- VRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Achondroplasia
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia
The trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with Achondroplasia.
- Trial name
- NCT04085523
- Testing
- TransCon CNP
- Where
- 15 sites in United States, Australia and 6 more
- Volunteers
- 57 people
- Sponsor
- Ascendis Pharma A/S
Malaria
Study of the Plasmodium Vivax Transmission-blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-blocking Activity in Healthy Malaria-naive Adults
Background: Malaria is a disease carried by mosquitoes in tropical countries around the world. It can cause symptoms like fever, body aches, and weakness.
- Trial name
- NCT05913973
- Testing
- Pvs230D1-EPA/Matrix-M
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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