Clinical trials: Dose Finding Study
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.
- Trial name
- NCT02848001
- Testing
- CC-90009
- Where
- 20 sites in United States, Canada and 4 more
- Volunteers
- 101 people
- Sponsor
- Celgene
Prostate Cancer
Phase II, Dose Finding Study of GTx-758
The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.
- Trial name
- NCT01393119
- Testing
- GTx-758
- Where
- 21 sites in United States
- Volunteers
- 77 people
- Sponsor
- GTx
Vulvodynia
Dysport in Vulvodynia Phase II Study
This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia.
- Trial name
- DYVINIA (NCT03598777)
- Testing
- Botulinum toxin type A
- Where
- 9 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Ipsen
Cancer
Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors
The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo.
- Trial name
- NCT00069277
- Testing
- E7389
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Eisai Inc.
Respiratory Syncytial Virus Infection
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
The primary objectives of the study were: To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
- Trial name
- VAD00001 (NCT04491877)
- Testing
- RSV vaccine formulation 1, RSV vaccine formulation 2
- Where
- 29 sites in United States, Chile and 1 more
- Volunteers
- 259 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.
- Conditions
- Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
- Trial name
- NCT02711345
- Testing
- LTT462
- Where
- 7 sites in United States, Germany and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
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
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
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
Anesthesia, General
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to…
- Trial name
- NCT00552617
- Testing
- Sugammadex, Rocuronium, Vecuronium
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Short Stature Children Born Small for Gestational Age (SGA)
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already…
- Trial name
- NCT03878446
- Testing
- Somapacitan, Norditropin®
- Where
- 95 sites in United States, Algeria and 21 more
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Healthy
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates.
- Trial name
- NCT02816346
- Testing
- Shigella sonnei 53G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PATH
Prostate Cancer Metastatic
Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen…
- Trial name
- NCT03646162
- Testing
- Veru-944
- Where
- 24 sites in United States
- Volunteers
- 93 people
- Sponsor
- Veru Inc.
Juvenile Idiopathic Arthritis
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate…
- Trial name
- SKYPP (NCT02776735)
- Testing
- Sarilumab
- Where
- 30 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Sanofi
Excessive Daytime Sleepiness, Parkinson Disease
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with…
- Trial name
- CASPAR (NCT03194217)
- Testing
- BEN-2001
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BenevolentAI Bio