Clinical trials: Dose Finding Study
Pain, Acute
Dose Finding Study of STR-324
This study aims to evaluate the analgesic effect and the safety of 4 doses of STR-324 administered as an infusion, with or without initial bolus, to patients suffering from post-operative pain.
- Trial name
- NCT04582786
- Testing
- Morphine, Morphine HCl, STR-324
- Where
- Netherlands
- Volunteers
- 118 people
- Sponsor
- Alaxia SAS
Adeno-Associated Virus (AAV), Blood Coagulation Disorder
Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with…
- Conditions
- Adeno-Associated Virus (AAV), Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders
- Trial name
- NCT03734588
- Testing
- SPK-8016
- Where
- 11 sites in United States
- Volunteers
- 4 people
- Sponsor
- Spark Therapeutics, Inc.
Atrial Fibrillation
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the…
- Trial name
- EXPLORE-Xa (NCT00742859)
- Testing
- betrixaban, Warfarin
- Where
- 21 sites in United States, Canada
- Volunteers
- 508 people
- Sponsor
- Portola Pharmaceuticals
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Trial name
- NCT06533579
- Testing
- Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- Vironexis Biotherapeutics Inc.
Pneumococcal Vaccines
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant…
- Trial name
- NCT05844423
- Testing
- 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20, 0.5 ml dose of 2.2 mcg VAX-24
- Where
- 32 sites in United States
- Volunteers
- 802 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Prostatic Neoplasms
A Study of CC-90011 and Comparators in Participants With Prostate Cancer
This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC -90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to…
- Trial name
- NCT04628988
- Testing
- CC-90011, Abiraterone, Prednisone
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Celgene
Knee Osteoarthritis
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray
- Trial name
- NCT00371670
- Testing
- balicatib (AAE581)
- Where
- 2 sites in United States, Germany
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus Type 2
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus.
- Trial name
- NCT00800176
- Testing
- RO4998452
- Where
- 67 sites in United States, Australia and 10 more
- Volunteers
- 394 people
- Sponsor
- Hoffmann-La Roche
Cytomegalovirus Infection
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
- Trial name
- NCT04232280
- Testing
- mRNA-1647
- Where
- 9 sites in United States
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Essential Hypertension
A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension
This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of…
- Trial name
- NCT00758524
- Testing
- LCI699, Eplerenone
- Where
- United States
- Volunteers
- 628 people
- Sponsor
- Novartis Pharmaceuticals
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
Mucopolysaccharidosis I
Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I
AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously.
- Trial name
- NCT02371226
- Testing
- AGT-181 (HIRMAb-IDUA)
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- ArmaGen, Inc
NSCLC
Study of Poziotinib in Japanese Patients With NSCLC
A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).
- Trial name
- NCT04402008
- Testing
- Poziotinib Once Daily Dosing, Poziotinib Twice Daily Dosing, Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1
- Where
- 3 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Contraception
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less…
- Trial name
- NCT01709318
- Testing
- Nomegestrol acetate (NOMAC), Etonogestrel (ENG), Ethinyl estradiol (EE)
- Volunteers
- 666 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Advanced Solid Tumors
A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
The study consisted of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase evaluated the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally…
- Trial name
- COMBO (NCT02994953)
- Testing
- Avelumab, M9241, Avelumab (Once weekly)
- Where
- 33 sites in United States, Belgium and 5 more
- Volunteers
- 52 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Bone Metastases From Solid Tumors
Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors
This is a randomized, open-label, dose-finding, multi-centre, phase Ⅰb study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.
- Trial name
- NCT04630522
- Testing
- Drug: JMT103- 120 mg SC Q4W, Drug: JMT103- 120 mg SC Q8W, Drug: JMT103- 180 mg SC Q8W
- Where
- China
- Volunteers
- 295 people
- Sponsor
- Shanghai JMT-Bio Inc.
Primary Open Angle Glaucoma, Ocular Hypertension
A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
- Trial name
- NCT00595101
- Testing
- PF-03187207, Latanoprost 0.005%, PF-03187207 Vehicle
- Where
- 13 sites in Japan
- Volunteers
- 117 people
- Sponsor
- Bausch & Lomb Incorporated
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy.
- Trial name
- NCT00928512
- Testing
- Secukinmab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 237 people
- Sponsor
- Novartis Pharmaceuticals
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.
Neoplastic Disease, Glioblastoma
131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of…
- Conditions
- Neoplastic Disease, Glioblastoma, Glioblastoma Multiforme
- Trial name
- IPAX-2 (NCT05450744)
- Testing
- 131I-IPA
- Where
- 5 sites in Australia, Austria and 1 more
- Volunteers
- 12 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
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