Clinical trials: PH1
Healthy Subjects
A Ph 1 Study of Epanova® in Healthy Chineses
The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population…
- Trial name
- NCT03574142
- Testing
- Epanova
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Malignant Solid Tumour
Ph1 Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Pts With Refractory Solid Tumors
This is a three-part open label phase 1 study designed to determine the safety profile, MTD, PK and tumor and biomarker response after IT or IV administration of a single dose of VSV-IFNβ-NIS, or combined IT followed by IV…
- Trial name
- NCT02923466
- Testing
- VSV-IFNβ-NIS, VSV-IFNβ-NIS and avelumab
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Vyriad, Inc.
Anthrax
Ph1 Study of Valortim and Doxycycline in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV doxycycline when administered concomitantly with IV Valortim in normal healthy human subjects.
- Trial name
- NCT00964834
- Testing
- Doxycycline and Valortim
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
HER2 Negative Metastatic Breast Cancer
Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers…
- Trial name
- NCT01948843
- Testing
- ADI-PEG 20
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Polaris Group
Metastatic Cancer, Unresectable Solid Tumor
CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer
Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer.
- Trial name
- NCT07057349
- Testing
- [18F]CSB-321
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cytosite Biopharma Inc.
GVHD, Chronic
TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))
1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics 2.
- Trial name
- NCT06169722
- Testing
- TDI01 suspension
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
Idiopathic Pulmonary Fibrosis (IPF)
TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis
This is a Phase 1, 4-part, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1058 inhaled solution.
- Trial name
- NCT04589260
- Testing
- TD-1058
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Primary Hyperoxaluria Type 1
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)
The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.
- Trial name
- BONAPH1DE (NCT04982393)
- Where
- 30 sites in United States, Belgium and 9 more
- Volunteers
- 207 people
- Sponsor
- Alnylam Pharmaceuticals
Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors
Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers…
- Trial name
- NCT01665183
- Testing
- ADI-PEG 20
- Where
- 2 sites in United States, Taiwan
- Volunteers
- 8 people
- Sponsor
- Polaris Group
Primary Hyperoxaluria Type 1, End Stage Renal Disease
Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD
The aim of this study is to evaluate DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis.
- Trial name
- PHYOX7 (NCT04580420)
- Testing
- DCR-PHXC
- Where
- 18 sites in United States, France and 8 more
- Volunteers
- 28 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).
- Trial name
- ILLUMINATE-C (NCT04152200)
- Testing
- Lumasiran
- Where
- 14 sites in United States, Australia and 9 more
- Volunteers
- 21 people
- Sponsor
- Alnylam Pharmaceuticals
Pancreatic Cancer
Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects
The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to determine a recommended Phase 2 dose (RP2D) for…
- Trial name
- NCT02651727
- Testing
- Part B, Cohort 1- VS-4718, nab-paclitaxel, gemcitabine, Part B, Cohort 2- VS4718, nab-paclitaxel, gemcitabine, Part A- VS-4718, nab-paclitaxel, gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Verastem, Inc.
Part A and B: Advanced Solid Malignancies, Part C: Malignant Mesothelioma
Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients…
- Trial name
- NCT02141347
- Testing
- Tremelimumab, MEDI4736
- Where
- 11 sites in Japan
- Volunteers
- 65 people
- Sponsor
- AstraZeneca
Actinic Keratosis
Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis
This is a phase 1 study to access the safety and tolerability of KX2-391 ointment in subjects who have Actinic Keratosis. This study will also access the amount of KX2-391 drug that enters the blood stream through dermal…
- Trial name
- NCT02337205
- Testing
- KX2-391 Ointment
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Athenex, Inc.
Primary Hyperoxaluria Type 1 (PH1)
Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects…
- Trial name
- NCT02706886
- Testing
- Lumasiran
- Where
- 9 sites in France, Germany and 3 more
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Advanced Melanoma, Metastatic Melanoma
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced…
- Trial name
- PD-1 (NCT01621490)
- Testing
- Nivolumab, Ipilimumab
- Where
- 14 sites in United States, Netherlands and 1 more
- Volunteers
- 170 people
- Sponsor
- Bristol-Myers Squibb
Retinal Dystrophy Due to Biallelic ABCA4 Mutations, Stargardt Disease 1
Safety and Preliminary Efficacy of VG801 in Patients With ABCA4 Mutation-associated Retinal Dystrophy (Stargardt Disease)
This is a single-arm, open-label, non-randomized, single dose-escalation, first-in-human (FIH) clinical trial to evaluate the safety and preliminary efficacy of VG801 for treatment of patients with retinal dystrophy (Stargardt…
- Trial name
- NCT07002398
- Testing
- VG801
- Where
- China
- Volunteers
- 18 people
- Sponsor
- VeonGen Therapeutics GmbH
Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD…
- Conditions
- Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia, Blast Crisis
- Trial name
- NCT02730312
- Testing
- XmAb14045
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Xencor, Inc.
Prophylaxis Against Plasmodium Falciparum Malaria
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720.
- Trial name
- NCT00284973
- Testing
- Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2)
Long Term Extension Study in Patients With Primary Hyperoxaluria
The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of…
- Conditions
- Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2), Kidney Diseases, Urologic Diseases
- Trial name
- PHYOX3 (NCT04042402)
- Testing
- DCR-PHXC
- Where
- 23 sites in United States, Australia and 11 more
- Volunteers
- 75 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company