Clinical trials: Tolerability
Healthy Subjects
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
- Trial name
- NCT07856706
- Testing
- ABBV-7828
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AbbVie
Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in patients with R/R NHL.
- Conditions
- Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, DLBCL, MYD88 Gene Mutation
- Trial name
- NCT05233033
- Testing
- KT-413
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Kymera Therapeutics, Inc.
Kidney Transplantation
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
- Trial name
- NCT01279538
- Testing
- bleselumab
- Where
- 21 sites in United States
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Hypertension, Dyslipidemia
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- Trial name
- NCT07682948
- Testing
- Investigational Product 1, Investigational Product 2, Investigational Product 1 + Investigational Product 2
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Melanoma, Cutaneous Malignant
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the…
- Trial name
- SUPRAME (NCT06743126)
- Testing
- IMA203, nivolumab plus relatlimab, lifileucel
- Where
- 71 sites in United States, Canada and 4 more
- Volunteers
- 360 people
- Sponsor
- Immatics US, Inc.
Healthy, Chronic Stable Illness
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
The primary objectives of the study are: To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna mRNA-1273 To evaluate the time…
- Trial name
- NCT04852978
- Testing
- casirivimab+imdevimab, Moderna mRNA-1273 vaccine
- Where
- 6 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Cocaine Use Disorder
Study to Assess Safety, Tolerability, and Interactions of Cocaine and Oral AFQ056
This is a study to assess safety, tolerability and interactions of AFQ056 and cocaine in patients with cocaine use disorder.
- Trial name
- NCT04771143
- Testing
- AFQ056
- Sponsor
- Novartis Pharmaceuticals
Amyotrophic Lateral Sclerosis
Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
- Trial name
- NCT04569435
- Testing
- ANX005
- Where
- 8 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Annexon, Inc.
AIDS
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected…
- Trial name
- RALAM (NCT02284035)
- Testing
- Raltegravir/3TC, EFV/TDF/FTC, ATV/r + TDF/FTC or DRV/r + TDF/FTC
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Juan A. Arnaiz
Prostate Cancer
Evaluating Tolerability of ePUHRT With Brachytherapy Boost
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external…
- Trial name
- NCT06817668
- Testing
- ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Indiana University
Post-Operative Nausea and Vomiting (PONV)
Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV)
The purpose of this study is to describe the safety and tolerability and pharmacokinetics of a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin (Captisol™) based, formulation in Healthy Adult…
- Trial name
- NCT01290133
- Testing
- GW597599
- Where
- Australia
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Accenture
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
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
Mixed Dyslipidemia, Hypercholesterolaemia
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk.
- Trial name
- MEDICI (NCT07614958)
- Where
- United Kingdom
- Volunteers
- 426 people
- Sponsor
- A. Menarini International Licensing S.A.
Multiple Myeloma (MM)
A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET Imaging and Histological Expression of 68Ga-NOTA-SCH001 in Patients With Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has…
- Trial name
- NCT06925958
- Testing
- Flow cytometry
- Volunteers
- 15 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Tourette Syndrome
A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome
This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome.
- Trial name
- NCT03651726
- Testing
- THX-110 (dronabinol plus PEA)
- Where
- 2 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Neurothera Labs Inc.
Solid Tumors
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.
- Trial name
- KEYNOTE-603 (NCT03313778)
- Testing
- mRNA-4157, Pembrolizumab, SoC Treatment
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 161 people
- Sponsor
- ModernaTX, Inc.
Ocular Inflammation and Pain After Cataract Surgery
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo.
- Trial name
- NCT04089735
- Testing
- APP13007, 0.05%, APP13007, 0.1%
- Where
- 9 sites in United States
- Volunteers
- 165 people
- Sponsor
- Formosa Pharmaceuticals, Inc.
Solid Tumor, Adult, NSCLC
Study to Evaluate D-1553 in Subjects With Solid Tumors
This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with…
- Conditions
- Solid Tumor, Adult, NSCLC, CRC
- Trial name
- NCT04585035
- Testing
- D-1553, D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other
- Where
- 25 sites in United States, Australia and 2 more
- Volunteers
- 180 people
- Sponsor
- InventisBio Co., Ltd
Moderate to Severe Plaque-type Psoriasis
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
- Trial name
- FEATURE (NCT01555125)
- Testing
- secukinumab 150 mg, secukinumab 300 mg
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals