Clinical trials: Dose Finding Study
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
- Trial name
- NCT02706834
- Testing
- TAK-828
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastrointestinal Cancer, Gastrointestinal Cancer Metastatic
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer
The primary objective of the phase 1 portion of this study is to determine the recommended dose of bemarituzumab in combination with 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) to use in the phase 2 portion of…
- Conditions
- Gastrointestinal Cancer, Gastrointestinal Cancer Metastatic, Gastric Cancer
- Trial name
- FIGHT (NCT03343301)
- Testing
- Bemarituzumab, Modified FOLFOX6
- Where
- 7 sites in United States
- Volunteers
- 12 people
- Sponsor
- Five Prime Therapeutics, Inc.
HIV Infections
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial.
- Trial name
- DOMINO (NCT04493216)
- Testing
- GSK3640254, ABC/3TC, FTC/TAF
- Where
- 65 sites in United States, Argentina and 9 more
- Volunteers
- 161 people
- Sponsor
- ViiV Healthcare
Chronic Kidney Disease, Hemodialysis
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
- Conditions
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
- Trial name
- DONATO (NCT01200784)
- Testing
- Nicotinamide
- Where
- 36 sites in Germany
- Volunteers
- 252 people
- Sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
Narcolepsy Type 2
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night.
- Trial name
- NCT06952699
- Testing
- TAK-360
- Where
- 52 sites in United States, China and 5 more
- Volunteers
- 88 people
- Sponsor
- Takeda
Alzheimer's Disease
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
The purpose of this study was to investigate the 5cm^2 and 10cm^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE [Mini Mental State Examination] 10-20).
- Trial name
- NCT00423085
- Testing
- Rivastigmine transdermal patch
- Where
- Japan
- Volunteers
- 859 people
- Sponsor
- Novartis Pharmaceuticals
Refractory and/or Unexplained Chronic Cough
Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC).
- Trial name
- PAGANINI (NCT04562155)
- Testing
- BAY1817080
- Where
- 99 sites in United States, Argentina and 17 more
- Volunteers
- 310 people
- Sponsor
- Bayer
Acute Respiratory Distress Syndrome
Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)
With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works.
- Trial name
- NCT04609943
- Testing
- BAY1211163
- Where
- 4 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Bayer
Procedural Sedation, Endoscopy
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
- Trial name
- NCT00869440
- Testing
- CNS 7056, Midazolam
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Paion UK Ltd.
COVID-19 (Healthy Volunteers)
Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine…
- Trial name
- NCT04742738
- Testing
- GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1, GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1
- Where
- 12 sites in South Korea
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
Osteoporosis
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
- Trial name
- NCT00542425
- Testing
- teriparatide, BA058 20 µg, BA058 40 µg
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Radius Health, Inc.
Solid Tumor, Adult, Breast Cancer
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced…
- Conditions
- Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Trial name
- NCT03149549
- Testing
- CX-2009
- Where
- 26 sites in United States, Netherlands and 2 more
- Volunteers
- 99 people
- Sponsor
- CytomX Therapeutics
Recurrent Melanoma (Skin), Metastatic Melanoma
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in…
- Conditions
- Recurrent Melanoma (Skin), Metastatic Melanoma, Melanoma Stage IV, Melanoma Stage III
- Trial name
- NCT05655312
- Testing
- [203Pb]VMT01, [212Pb]VMT01, Nivolumab
- Where
- 16 sites in United States
- Volunteers
- 300 people
- Sponsor
- Perspective Therapeutics
Migraine
A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these…
- Trial name
- PROCEED (NCT06323928)
- Testing
- Lu AG09222
- Where
- 120 sites in United States, Bulgaria and 12 more
- Volunteers
- 874 people
- Sponsor
- H. Lundbeck A/S
X-linked Hypophosphatemia
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
The objectives of the study are to: Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants Establish the safety profile of burosumab for the treatment of…
- Trial name
- NCT02163577
- Testing
- burosumab
- Where
- 9 sites in United States, France and 2 more
- Volunteers
- 52 people
- Sponsor
- Kyowa Kirin, Inc.
General Anesthesia
Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study. Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy…
- Trial name
- NCT07404306
- Testing
- HSK3486, propofol
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
Non-Small Cell Lung Cancer
Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.
- Trial name
- NCT02584634
- Testing
- Avelumab, PF-06463922, Crizotinib
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
COVID-19
Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults
This is a phase 1 study to assess the safety and immunogenicity of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine (SCB-2020S vaccine), when…
- Trial name
- NCT05228314
- Testing
- Candidate vaccine, SCB-2020S, Candidate vaccine, SCB-2019, Squalene based adjuvant
- Where
- 3 sites in South Africa
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Clover Biopharmaceuticals AUS Pty
Infertility
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women…
- Trial name
- NCT00505752
- Testing
- AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg, AS900672-Enriched 150 mcg
- Where
- United States
- Volunteers
- 520 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Contraception
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in…
- Trial name
- NCT04682353
- Testing
- TV-46046, Depo-subQ Provera
- Where
- 3 sites in United States, Dominican Republic
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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