Clinical trials: Safety and Tolerability
Neoplasms, Carcinoma, Non-Small-Cell Lung
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.
- Conditions
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03948763
- Testing
- V941, Pembrolizumab
- Where
- 26 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
GM2 Gangliosidosis, Niemann-Pick Type C Disease
A Study to Evaluate the Safety and Efficacy of Nizubaglustat (AZ-3102) in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease
This open-label study aims to gather long-term safety, tolerability, PK, biomarker, and clinical efficacy data relating to daily administration of Nizubaglustat in participants previously enrolled in the Phase 2 RAINBOW study…
- Trial name
- PRISMA (NCT07399704)
- Testing
- AZ-3102
- Where
- 3 sites in Brazil
- Volunteers
- 21 people
- Sponsor
- Azafaros B.V.
Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
- Conditions
- Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1
- Trial name
- NCT05735184
- Testing
- Ziftomenib, Venetoclax, Azacitidine
- Where
- 44 sites in United States
- Volunteers
- 420 people
- Sponsor
- Kura Oncology, Inc.
Depression
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
- Trial name
- NCT00610649
- Testing
- MK-8777
- Volunteers
- 54 people
- Sponsor
- Merck Sharp & Dohme LLC
Hemophilia A
Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs
This is a multi-center, Phase 1/2/3, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H803 injection in severe Hemophilia A subjects.
- Trial name
- NCT06111638
- Testing
- Single dose intravenous injection of BBM-H803
- Where
- 10 sites in China
- Volunteers
- 55 people
- Sponsor
- Shanghai Xinzhi BioMed Co., Ltd.
Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent /…
- Conditions
- Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors
- Trial name
- STAR-TOR (NCT00700258)
- Testing
- Temsirolimus, Sunitinib, Axitinib
- Where
- 77 sites in Germany
- Volunteers
- 1,520 people
- Sponsor
- Pfizer
Major Depressive Disorder, Insomnia
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
- Trial name
- NCT03771664
- Testing
- SAGE-217
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Biogen
Shock, Septic
Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.
- Trial name
- ASTONISH (NCT04055909)
- Testing
- nangibotide low dose, nangibotide high dose
- Where
- 43 sites in Belgium, Denmark and 4 more
- Volunteers
- 355 people
- Sponsor
- Inotrem
Tumors, Lymphoma
Safety Study of Ridaforolimus in Patients With Advanced, Refractory or Recurrent Malignancies (MK-8669-001 AM5)(COMPLETED)
Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of ridaforolimus in patients with refractory or recurrent malignancies, including myeloma and lymphoma.
- Conditions
- Tumors, Lymphoma, Multiple Myeloma
- Trial name
- NCT00060632
- Testing
- ridaforolimus
- Volunteers
- 46 people
- Sponsor
- Merck Sharp & Dohme LLC
Xerostomia, Sjogren's Syndrome
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.
- Trial name
- NCT00637793
- Testing
- NGX267
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- TorreyPines Therapeutics
Diagnostic Imaging
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.
- Trial name
- NCT01205321
- Testing
- Bombesin (68Ga) labeled (BAY86-7548)
- Where
- 3 sites in Finland, Germany and 1 more
- Volunteers
- 19 people
- Sponsor
- Lantheus Biosciences Ltd.
COVID-19
Clinical Study of F61 Injection in Healthy Chinese Subjects
Main purpose： To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects. Secondary purpose： To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by…
- Trial name
- NCT05483504
- Testing
- F61 injection
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wuhan Institute of Biological Products Co., Ltd
Cystic Fibrosis
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects (Phase 1) and of two doses in Adults with Cystic Fibrosis (Phase 1b).
- Trial name
- NCT05712538
- Testing
- ARCT-032
- Where
- New Zealand
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Arcturus Therapeutics, Inc.
Asthma
Single and Multiple Ascending Dose Study of TD-8236 by Inhalation
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in…
- Trial name
- NCT03652038
- Testing
- TD-8236
- Where
- 2 sites in United Kingdom
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Rift Valley Fever
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following intramuscular (IM )administration of single ascending doses to healthy…
- Trial name
- NCT06925919
- Testing
- IDB-011 dose level 1, IDB-011 dose level 2, IDB-011 dose level 3
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IDBiologics, Inc.
Viral Respiratory Tract Infection
Safety and Tolerability of Single and Multiple Doses of Neumifil
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of…
- Trial name
- NCT05093530
- Testing
- Neumifil
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pneumagen Ltd.
Nonalcoholic Steatohepatitis
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period. Period: 24 hours post dose in each period. Each subject will complete two study periods.
- Trial name
- NCT05983328
- Testing
- HUYPS-1 one tablet, HUYPS-1 nine tablets
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
Hyperphosphatemia, End-stage Renal Disease
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
- Trial name
- NCT00648167
- Testing
- ferric citrate
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Keryx Biopharmaceuticals
Lupus Erythematosus, Systemic
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms.
- Trial name
- OPUS-1 (NCT05648500)
- Testing
- Cenerimod
- Where
- 198 sites in United States, Argentina and 15 more
- Volunteers
- 470 people
- Sponsor
- Viatris Innovation GmbH
Gastroenterology
Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases.
- Trial name
- NCT06515834
- Testing
- FE 999301
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals