Clinical trials: Tolerability
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated
The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.
- Trial name
- NCT04978506
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Primary Mitochondrial Disease
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in…
- Trial name
- NCT02976038
- Testing
- elamipretide
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Stealth BioTherapeutics Inc.
Chronic Obstructive Pulmonary Disease (COPD)
Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD
The purpose of this study is to evaluate discontinuation rates of roflumilast using an up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of 500 μg one daily (OD) during the entire 12-week…
- Trial name
- OPTIMIZE (NCT02165826)
- Testing
- Roflumilast, Standard of Care COPD Treatment
- Where
- 2 sites in Slovakia
- Volunteers
- 1,323 people
- Sponsor
- AstraZeneca
Neuroendocrine Tumor, Gastrointestinal Neoplasm
A Study of XmAb®18087 in Subjects With NET and GIST
This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK…
- Trial name
- NCT03411915
- Testing
- XmAb18087
- Where
- 16 sites in United States
- Volunteers
- 62 people
- Sponsor
- Xencor, Inc.
Healthy, Overweight and/or Obese Subjects
Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese Subjects
Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
- Trial name
- NCT01764425
- Testing
- P7435
- Where
- 2 sites in India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Piramal Enterprises Limited
Ovarian Cancer, Lung Adenocarcinoma
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced…
- Conditions
- Ovarian Cancer, Lung Adenocarcinoma, Endometrial Cancer, Lung Squamous Cell Carcinoma
- Trial name
- FONTANA (NCT05797168)
- Testing
- Torvutatug samrotecan, Saruparib, Bevacizumab
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 622 people
- Sponsor
- AstraZeneca
Healthy Participants
A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants
The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.
- Trial name
- NCT06140290
- Testing
- Etrasimod Immediate Release (IR)
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV-1-infection
Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women
The goals of this clinical study are to learn more about the study drugs, VRC07-523LS, CAP256V2LS, and vesatolimod (VES) and how safe it is in women that have HIV and are on antiretroviral therapy (ART).
- Trial name
- NCT05281510
- Testing
- Vesatolimod, VRC07523LS, CAP256V2LS
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Gilead Sciences
Healthy
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers
The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
- Trial name
- NCT02198313
- Testing
- BIIX 1 XX - D1, BIIX 1 XX - D2, BIIX 1 XX - D3
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Gout
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting…
- Trial name
- NCT03291782
- Testing
- D-0120
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Schizophrenia
Study Evaluating Vabicaserin in Subjects With Schizophrenia
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
- Trial name
- NCT00563706
- Testing
- vabicaserin, risperidone
- Where
- 33 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Pfizer
Advanced Solid Tumor
Study SC-101 in Subjects With Advanced Malignancies
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
- Trial name
- NCT06220838
- Testing
- SC-101
- Where
- 5 sites in China
- Volunteers
- 100 people
- Sponsor
- Tianjin ConjuStar Biologics Co., Ltd.
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
A Study of EDP-297 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Trial name
- NCT04559126
- Testing
- EDP-297
- Where
- Netherlands
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Thyroid Eye Disease
A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease
The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.
- Trial name
- NCT06389578
- Testing
- Teprotumumab
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Amgen
Infection, Bacterial
A First-in-Human Study With XAB05 in Healthy Subjects
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
- Trial name
- NCT05307406
- Testing
- Experimental
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Xenothera SAS
Type 2 Diabetes Mellitus
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin
- Trial name
- NCT01055652
- Testing
- Dapagliflozin
- Where
- 2 sites in Japan
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
Covid19 Vaccine
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study
The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21
- Trial name
- NCT05048849
- Testing
- MVC-COV1901(S protein with adjuvant)
- Where
- 11 sites in Taiwan
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obesity
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2.
- Trial name
- NCT03625778
- Testing
- MEDI0382
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- MedImmune LLC
Lung Injury, Acute
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).
- Trial name
- NCT01597635
- Testing
- Dose 1 GSK2586881, Dose 2 GSK2586881, Dose 3 GSK2586881
- Where
- 19 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- GlaxoSmithKline
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