Clinical trials: Dose Finding Study
Friedreich's Ataxia (FA)
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
This is a phase 1b, first in-human, open-label, dose-finding study investigating the safety and tolerability of SGT-212 in participants with Friedreich's ataxia (FA).
- Trial name
- FALCON (NCT07180355)
- Testing
- SGT-212
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solid Biosciences Inc.
Analgesia
Pediatric Postoperative Analgesia Herniorrhaphy Study
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
- Trial name
- NCT03922048
- Testing
- HTX-011, Bupivacaine HCl, Luer Lock Applicator
- Sponsor
- Heron Therapeutics
Ornithine Transcarbamylase (OTC) Deficiency
Safety and Dose-Finding Study of DTX301 (scAAV8OTC) in Adults With Late-Onset Ornithine Transcarbamylase (OTC) Deficiency
This is a Phase 1/2, open-label, single arm, multicenter, safety and dose finding study of DTX301 in adults with late-onset OTC deficiency.
- Trial name
- CAPtivate (NCT02991144)
- Testing
- scAAV8OTC, Reactive Corticosteroid Taper Regimen, Prophylactic Corticosteroid Taper Regimen
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 16 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants
The purpose of this study is to characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults.
- Trial name
- NCT02153099
- Testing
- TAK-058 (ENV8058)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Carcinoma, Hepatocellular
Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer
CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in combination with sorafenib for subjects with unresectable HCC who have received no prior systemic therapy for HCC.
- Trial name
- NCT02323906
- Testing
- CC-122, Sorafenib
- Where
- 8 sites in United States
- Volunteers
- 12 people
- Sponsor
- Celgene
Hepatitis C, Chronic
Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection
Primary objectives: The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups.
- Trial name
- NCT01587586
- Testing
- PEGASYS 180 µg Q1W, P1101 180 µg Q1W, 48 doses, P1101 270µg Q1W, 48 doses
- Where
- 13 sites in Taiwan
- Volunteers
- 107 people
- Sponsor
- PharmaEssentia
Non-cystic Fibrosis Bronchiectasis
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens…
- Trial name
- NCT07048262
- Testing
- CSL787, Nebulizer
- Where
- 13 sites in Australia, Japan
- Volunteers
- 180 people
- Sponsor
- CSL Behring
Parkinson's Disease, Dyskinesia
Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
- Trial name
- NCT00314288
- Testing
- Sarizotan HCl
- Where
- 51 sites in United States, Belgium and 9 more
- Volunteers
- 360 people
- Sponsor
- EMD Serono
Childhood Absence Epilepsy, Juvenile Absence Epilepsy
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
- Trial name
- EXPAND (NCT04666610)
- Testing
- Brivaracetam
- Where
- 35 sites in United States, Georgia and 5 more
- Volunteers
- 154 people
- Sponsor
- UCB Biopharma SRL
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.
Heavy Menstrual Bleeding
Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the…
- Trial name
- NCT06814028
- Testing
- Volta System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Spark Biomedical, Inc.
Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD)
A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201. All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4…
- Conditions
- Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD), BRVO - Branch Retinal Vein Occlusion
- Trial name
- NCT06664502
- Testing
- EYE201
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 38 people
- Sponsor
- EyeBiotech Ltd.
Healthy Volunteers
Dose-finding Pharmacokinetic Study in Healthy Males
This is a phase I PK study in healthy males.
- Trial name
- COMDOS1 (NCT03055936)
- Testing
- Levodopa, Carbidopa, ODM-104
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Advanced Solid Tumors
A Study of MRG003 in Patients With Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors…
- Trial name
- NCT04868344
- Testing
- MRG003
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Growth Hormone-Deficiency
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
- Trial name
- NCT02092077
- Testing
- TV-1106, somatropin
- Where
- 34 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 65 people
- Sponsor
- Teva Pharmaceutical Industries, Ltd.
Pain, Diabetic Peripheral Neuropathy
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.
- Trial name
- NCT01504412
- Testing
- DS-5565, Pregabalin capsules
- Where
- 3 sites in Japan, South Korea and 1 more
- Volunteers
- 450 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Idiopathic Pulmonary Fibrosis
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis (IPF).
- Trial name
- ZAPPHIRE (NCT07516951)
- Testing
- CHF10067
- Where
- 19 sites in United States, North Macedonia and 2 more
- Volunteers
- 240 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hepatitis C, Chronic
A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4
This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients…
- Trial name
- NCT00869661
- Testing
- Copegus, Pegasys, RO5024048
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 413 people
- Sponsor
- Hoffmann-La Roche
Post-Operative Pain
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectomy
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, placebo-controlled study.
- Trial name
- NCT02992041
- Testing
- VVZ-149 Injections
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Vivozon, Inc.
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients…
- Trial name
- NCT00424346
- Testing
- Canakinumab
- Where
- 17 sites in United States, Austria and 4 more
- Volunteers
- 274 people
- Sponsor
- Novartis
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