Clinical trials: Phase I
Parkinson Disease Psychosis, Amyotrophic Lateral Sclerosis (ALS)
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
- Trial name
- NCT05995782
- Testing
- FB418
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- 1ST Biotherapeutics, Inc.
Alzheimer Disease, Healthy Volunteers
Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein
The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
- Trial name
- NCT03071224
- Testing
- [18F] MNI-946, [18F]Florbetapir
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Invicro
COVID-19
A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
- Trial name
- NCT04691180
- Testing
- BRII-196 and BRII-198
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Brii Biosciences Limited
Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC)
A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)").
- Conditions
- Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors
- Trial name
- BrILliance (NCT06413680)
- Testing
- REGN10597, Cemiplimab
- Where
- 11 sites in United States
- Volunteers
- 240 people
- Sponsor
- Regeneron Pharmaceuticals
Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose…
- Conditions
- Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Metastatic Urothelial Cancer
- Trial name
- ASCENT-J02 (NCT05101096)
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 36 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Gilead Sciences
Non-Hodgkins Lymphoma
Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma
The purpose of this study is to investigate the ability to combine a radioactive medication directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem cell transplant.
- Trial name
- NCT00807196
- Testing
- Rituximab, 90Y ibritumomab tiuxetan (Zevalin), Cyclophosphamide
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Maisonneuve-Rosemont Hospital
Healthy
A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults
The primary objectives of this study are to determine the effect of multiple doses of itraconazole on the single dose PK of ALXN2080, to determine the effect of multiple doses of fluconazole on the single dose PK of ALXN2080…
- Trial name
- NCT06173596
- Testing
- ALXN2080, Itraconazole, Fluconazole (AxMP)
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neoplasms
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly.
- Trial name
- NCT00998296
- Testing
- BIBW 2992, BIBF 1120
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Boehringer Ingelheim
Infection, Human Immunodeficiency Virus
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of…
- Trial name
- NCT01231542
- Testing
- GSK1349572, Rifampin, Rifabutin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Prostate Cancer, Prostatectomy
High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
The goal of this observational study is to learn about the long-term effects of HDR Brachytherapy in men with isolated local relapses after radical prostatectomy.
- Conditions
- Prostate Cancer, Prostatectomy, Local Recurrence of Malignant Tumor of Prostate, Radiotherapy; Complications
- Trial name
- NCT06982469
- Testing
- Brachytherapy
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Healthy Volunteers
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants
This is a first-in-human study of NH302 injection in healthy participants. The study will test single intravenous doses of NH302 to evaluate its safety and tolerability, how the body processes NH302, and its effects on selected…
- Trial name
- NCT07892469
- Testing
- NH302 injection
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- The Third Xiangya Hospital of Central South University
Cancer
High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill…
- Trial name
- NCT00002854
- Testing
- filgrastim, carboplatin, cisplatin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- City of Hope Medical Center
Healthy
Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
- Trial name
- NCT05058105
- Testing
- FL058 500mg and Meropenem 1000mg( IV 120min), FL058 1000mg( IV 120min), Meropenem 1000 mg ( IV 120min)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Cancer, Advanced Cancer
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population.
- Conditions
- Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor
- Trial name
- NCT06440005
- Testing
- AGX101
- Where
- 7 sites in United States
- Volunteers
- 80 people
- Sponsor
- Angiex, Inc.
HIV Infection
A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the…
- Trial name
- 2009-016578-34 (NCT01571466)
- Testing
- Vaccination
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Hospital Clinic of Barcelona
Ulcerative Colitis, FMT
Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)
The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors.
- Conditions
- Ulcerative Colitis, FMT, Fecal Microbiota Transplant
- Trial name
- REFOCUS (NCT04968951)
- Testing
- Metronidazole, Vancomycin, Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Ari M Grinspan
Healthy
A Study of HM11260C in Healthy Male Subject
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.
- Trial name
- NCT01093729
- Testing
- HM11260C
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Esophageal Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
- Trial name
- NCT00002631
- Testing
- chemotherapy, cisplatin, fluorouracil
- Where
- 18 sites in United States, Canada
- Volunteers
- 298 people
- Sponsor
- Radiation Therapy Oncology Group
HIV Infections
A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC
To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of atevirdine mesylate ( U-87201E ) in HIV-infected patients.
- Trial name
- NCT00000753
- Testing
- Atevirdine mesylate, Zidovudine, Zalcitabine
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Advanced Cancer, Advanced Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as…
- Trial name
- NCT06656390
- Testing
- ALK201
- Where
- 38 sites in United States, Australia and 1 more
- Volunteers
- 202 people
- Sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.
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