Clinical trials: Dose Finding Study
Geographic Atrophy Secondary to Age-related Macular Degeneration
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Trial name
- NCT07441642
- Testing
- FWY003
- Where
- 59 sites in United States, Argentina and 16 more
- Volunteers
- 272 people
- Sponsor
- Novartis Pharmaceuticals
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
Kidney Transplantation
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
- Trial name
- AEB071 (NCT00504543)
- Testing
- AEB071, Certican, Neoral
- Where
- 26 sites in Argentina, Australia and 15 more
- Volunteers
- 311 people
- Sponsor
- Novartis Pharmaceuticals
NON-breast HER2+ Malignancies
Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
- Trial name
- NCT03696771
- Testing
- NJH395
- Where
- 4 sites in United States, Italy and 2 more
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Irritable Bowel Syndrome With Constipation
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
- Trial name
- NCT00460811
- Testing
- Linaclotide Acetate
- Where
- 85 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Acute Kidney Injury
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
- Trial name
- STOP-AKI (NCT02182440)
- Testing
- recAP
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 301 people
- Sponsor
- AM-Pharma
Catecholaminergic Polymorphic Ventricular Tachycardia
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
This is a Phase 1b, Multicenter, Open-Label, Dose Finding Study to Investigate the Safety and Tolerability of a Single Intravenous Dose of SGT-501 in participants with catecholaminergic polymorphic ventricular tachycardia (CPVT).
- Trial name
- ARTEMIS (NCT07148089)
- Testing
- SGT-501
- Where
- 5 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Solid Biosciences Inc.
Solid Tumor
A DRF Study to Evaluate Safety, Tolerability, PK, and Activity of Oradoxel Monotherapy in Subjects w Adv. Malignancies
This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to determine the MTD and optimal dosing regimen of Oradoxel. No control group has been included.
- Trial name
- NCT02963168
- Testing
- Oradoxel
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Athenex, Inc.
Actinic Keratosis Olsen Grade I/II
Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis
In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation.
- Trial name
- NCT01757613
- Testing
- AK 3012
- Where
- 9 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Dolorgiet GmbH & Co. KG
Diabetes Mellitus, Type 1, Diabetic Polyneuropathy
Effect of C-Peptide on Diabetic Peripheral Neuropathy
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.
- Trial name
- NCT00278980
- Testing
- C-peptide
- Where
- Sweden
- Volunteers
- 180 people
- Sponsor
- Creative Peptides Sweden Inc.
Multiple Myeloma
A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma
Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma. This is designed as a two-part study.
- Trial name
- NCT03288480
- Testing
- PT-112
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Promontory Therapeutics Inc.
Metastatic Breast Cancer
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
- Trial name
- DB-08 (NCT04556773)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
Chronic Kidney Disease
Study of Phosphate Levels in Patients With Chronic Kidney Disease
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
- Trial name
- PA21 (NCT00824460)
- Testing
- 1.25 g PA21 (250 mg iron), 5.0 g PA21 (1,000 mg iron), 7.5 g PA21 (1,500 mg iron)
- Where
- 60 sites in United States, Bulgaria and 7 more
- Volunteers
- 154 people
- Sponsor
- Vifor Pharma
Sentinel Lymph Node Biopsy, Breast Cancer
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control.
- Conditions
- Sentinel Lymph Node Biopsy, Breast Cancer, Melanoma
- Trial name
- NCT05457842
- Testing
- pudexacianinium chloride
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Astellas Pharma Inc
Acne Vulgaris
Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients
The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.
- Trial name
- NCT01362010
- Testing
- Topical Minocycline Foam FXFM244
- Where
- 3 sites in Israel
- Volunteers
- 150 people
- Sponsor
- Vyne Therapeutics Inc.
Rheumatoid Arthritis
Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients
Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.
- Trial name
- NCT02076659
- Testing
- F8IL10, Methotrexate
- Where
- 5 sites in Italy
- Volunteers
- 36 people
- Sponsor
- Philogen S.p.A.
Hypoactive Sexual Desire Disorder
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive…
- Trial name
- NCT02101203
- Testing
- 0.5 mgTestosterone + 10 mg Buspirone
- Where
- 10 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Emotional Brain NY Inc.
Healthy
A Study in Healthy Men to Find the Best Formulation of BI 685509 and to Test How it is Taken up in the Body
The main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed.
- Trial name
- NCT04926246
- Testing
- R1: Reference Product X, T1: Test Product M, T2: Test Product N
- Where
- United Kingdom
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Solid Tumor, Adult, Head and Neck Cancer
PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced…
- Conditions
- Solid Tumor, Adult, Head and Neck Cancer, Non Small Cell Lung Cancer, Diffuse Large B Cell Lymphoma
- Trial name
- NCT03543813
- Testing
- CX-2029
- Where
- 25 sites in United States, South Korea and 2 more
- Volunteers
- 133 people
- Sponsor
- CytomX Therapeutics
Glioblastoma Multiforme
A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
A study of single-agent birabresib (MK-8628) (formerly known as OTX015) in recurrent GBM after standard front-line therapy failure. The first phase of the study (dose escalation) will determine the maximum tolerated dose (MTD).
- Trial name
- NCT02296476
- Testing
- Birabresib
- Volunteers
- 12 people
- Sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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