Clinical trials: Dose Finding Study
Colorectal Cancer, Breast Cancer
Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors
SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in…
- Conditions
- Colorectal Cancer, Breast Cancer, Pancreas Cancer, Ovarian Cancer
- Trial name
- NCT04640480
- Testing
- SNB-101
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- SN BioScience
Respiratory Tract Infection
A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may…
- Trial name
- NCT03572062
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- 16 sites in United States, Australia
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Pfizer
Osteoarthritis of the Knee
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects…
- Trial name
- NCT02067611
- Testing
- X0002
- Where
- 20 sites in United States
- Volunteers
- 216 people
- Sponsor
- Lina Xu
Neuralgia, Shingles
Dose-Finding Study of REN-1654 in Patients With Post-Herpetic Neuralgia
The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with painful post-herpetic neuralgia (PHN).
- Conditions
- Neuralgia, Shingles, Peripheral Nervous System Disease
- Trial name
- NCT00099528
- Testing
- REN-1654
- Where
- 16 sites in United States
- Volunteers
- 90 people
- Sponsor
- Renovis
Ulcerative Colitis
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated.
- Trial name
- PROREM UC (NCT03415711)
- Testing
- VSL#3®, Mesalamine
- Where
- Italy
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- VSL Pharmaceuticals
Acute Respiratory Distress Syndrome
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
Evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of CT303 in patients with ARDS.
- Trial name
- NCT05238532
- Testing
- CT303
- Where
- 3 sites in South Korea
- Sponsor
- GC Cell Corporation
Disseminated Intravascular Coagulation
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by…
- Trial name
- NCT00506519
- Testing
- Antithrombin alfa (INN name), Control (Standard treatment)
- Volunteers
- 25 people
- Sponsor
- LEO Pharma
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Obesity, Overweight
A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight
This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight.
- Trial name
- NCT07662122
- Testing
- BI 3034701
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 344 people
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
In this study, researchers will learn how the heart reacts to multiple doses of BIIB091 in healthy participants. In previous studies looking at BIIB091, researchers have found that a certain range of doses can cause changes in…
- Trial name
- NCT06574828
- Testing
- BIIB091, Moxifloxacin
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Biogen
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Anxiety Disorder Generalized
А Dose-finding Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding pilot study to assess the efficacy and safety of CD-008-0045 in patients with Generalized Anxiety Disorder (GAD).
- Trial name
- NCT04524975
- Testing
- CD-008-0045
- Where
- 15 sites in Russia
- Volunteers
- 129 people
- Sponsor
- ChemRar Research and Development Institute, LLC
Hypercholesterolemia
Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of…
- Trial name
- NCT00404001
- Testing
- MD-0727
- Where
- 20 sites in United States
- Volunteers
- 150 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Diabetic Macular Edema
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
- Trial name
- MIVI-II (NCT00412451)
- Testing
- ocriplasmin
- Where
- 15 sites in Belgium, Germany and 4 more
- Volunteers
- 51 people
- Sponsor
- ThromboGenics
Idiopathic Short Stature
A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and…
- Trial name
- NCT07450053
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Parkinson's Disease
A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant…
- Trial name
- NCT02096601
- Testing
- LD/CD SC solution, Entacapone
- Where
- 2 sites in Israel
- Volunteers
- 16 people
- Sponsor
- NeuroDerm Ltd.
Gout and Hyperuricemia
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in…
- Trial name
- NCT02078219
- Testing
- RDEA3170, Allopurinol
- Where
- 14 sites in Japan
- Volunteers
- 204 people
- Sponsor
- AstraZeneca
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Rheumatoid Arthritis
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic…
- Trial name
- AUGUST I (NCT00430495)
- Testing
- Atacicept
- Where
- 2 sites in United States, Canada
- Volunteers
- 256 people
- Sponsor
- EMD Serono
Japanese Encephalitis Virus Disease
A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
This is a 2-Stage, Phase I/II Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)
- Trial name
- NCT06680128
- Testing
- GBP560-A, GBP560-B, IXIARO
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
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