Clinical trials: Dose Finding Study
Lung Cancer, Pancreatic Cancer
Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer
The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.
- Conditions
- Lung Cancer, Pancreatic Cancer, Esophageal Cancer
- Trial name
- NCT00101907
- Testing
- AMG 706, Panitumumab, Gemcitabine
- Volunteers
- 41 people
- Sponsor
- Amgen
Gout, Hyperuricemia
A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
IBI128 (Tigulixostat) is a novel non-purine selective inhibitor of xanthine oxidase (XO). The XO inhibitors lower uric acid concentrations in serum by inhibiting the production of uric acid.
- Trial name
- NCT06501534
- Testing
- Febuxostat, IBI128
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Neutropenia
A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy.
- Trial name
- NCT02521441
- Testing
- F-627, Filgrastim
- Where
- China
- Volunteers
- 138 people
- Sponsor
- EVIVE Biotechnology
Colitis, Ulcerative
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral…
- Trial name
- NCT00317356
- Testing
- OPC-6535(Tetomilast)
- Where
- 8 sites in Japan
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Neurogenic Detrusor Overactivity
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity.
- Trial name
- NCT00712322
- Testing
- Darifenacin
- Where
- 12 sites in United States, Colombia
- Volunteers
- 35 people
- Sponsor
- Warner Chilcott
NGLY1 Deficiency
Safety and Efficacy of GS-100 Gene Therapy in Patients With NGLY1 Deficiency
A non-randomized, open-label, Phase 1/2/3 study of a single intracerebroventricular (ICV) administration of a gene replacement therapy (GS-100) in participants who are 2 to 18 years old with NGLY1 Deficiency.
- Trial name
- NCT06199531
- Testing
- GS-100
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Grace Science, LLC
Neoplasms, NUT Carcinoma
BI 894999 First in Human Dose Finding Study in Advanced Malignancies
This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful.
- Trial name
- NCT02516553
- Testing
- BI 894999
- Where
- 16 sites in United States, Belgium and 4 more
- Volunteers
- 174 people
- Sponsor
- Boehringer Ingelheim
Intermittent Claudication
Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication
The purpose of this study is to evaluate the safety and pharmacokinetics of multiple, once-daily, intravenous doses of trans sodium crocetinate (TSC).
- Trial name
- NCT00725881
- Testing
- Trans sodium crocetinate (TSC), 0.9% normal saline
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Diffusion Pharmaceuticals Inc
Ulcerative Colitis
Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis
The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).
- Trial name
- NCT00303381
- Testing
- Interferon-beta-1a, 44 microgram, Interferon-beta-1a, 66 microgram
- Where
- 7 sites in Germany, Israel and 5 more
- Volunteers
- 194 people
- Sponsor
- EMD Serono
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis C Infection, Genotype 1
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
- Trial name
- NCT01194037
- Testing
- recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a, Ribavirin
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- HanAll BioPharma Co., Ltd.
Alzheimer's Disease
Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease
The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary objectives being to explore the relationship…
- Trial name
- ANAVEX (NCT02244541)
- Testing
- ANAVEX2-73 Oral, ANAVEX2-73 Intravenous
- Where
- 5 sites in Australia
- Volunteers
- 32 people
- Sponsor
- Anavex Life Sciences Corp.
Smallpox
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.
- Trial name
- NCT00189956
- Testing
- IMVAMUNE (MVA-BN)
- Where
- Switzerland
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Asthma Patients
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
- Trial name
- Sweapea (NCT01197794)
- Testing
- AZD1981
- Where
- 105 sites in United States, Argentina and 8 more
- Volunteers
- 1,144 people
- Sponsor
- AstraZeneca
Healthy
Dose-finding PKPD Trial for RE02 in Healthy Subjects
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability of three different doses against a placebo…
- Trial name
- NCT05979727
- Testing
- RE02, Manitol
- Where
- Switzerland
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Reconnect Labs
Acute Graft Versus Host Disease
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while…
- Trial name
- NCT00032773
- Testing
- pentostatin for injection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar.
- Trial name
- NCT04153929
- Testing
- BI 456906, Semaglutide
- Where
- 80 sites in United States, Australia and 12 more
- Volunteers
- 413 people
- Sponsor
- Boehringer Ingelheim
Lateral Canthal Lines, Crow's Feet
Dose Finding Study In Subjects With Crow's Feet
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
- Trial name
- NCT01951742
- Testing
- ANT-1401, Vehicle
- Where
- 10 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Anterios Inc.
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Heart Failure
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced…
- Trial name
- NCT01951625
- Testing
- Vericiguat (BAY1021189) (1.25 mg), Vericiguat (BAY1021189) (5 mg)
- Where
- 157 sites in United States, Australia and 22 more
- Volunteers
- 456 people
- Sponsor
- Bayer
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