Clinical trials: Dose Escalation and Safety
Chronic Obstructive Pulmonary Disease
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.
- Trial name
- NCT01013142
- Testing
- MN-221 (Dose Group 1), MN-221 (Dose Group 2), MN-221 (Dose Group 3)
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- MediciNova
Leber Hereditary Optic Neuropathy
Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients
The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.
- Trial name
- NCT02064569
- Testing
- GS010
- Where
- France
- Volunteers
- 19 people
- Sponsor
- GenSight Biologics
Advanced or Metastatic Solid Tumors, Cancer
A Dose Escalation Study of SF1126, a PI3 Kinase (PI3K) Inhibitor, Given By Intravenous (IV) Infusion in Patients With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of SF1126 in patients with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and defining the maximum tolerated dose given twice…
- Conditions
- Advanced or Metastatic Solid Tumors, Cancer, Solid Cancers
- Trial name
- SF112600106 (NCT00907205)
- Testing
- SF1126
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Semafore Pharmaceuticals
Multiple Myeloma
A Study Evaluating Safety, Tolerability and Clinical Activity of FHND6091 in Patients With Multiple Myeloma
This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory…
- Trial name
- NCT05271682
- Testing
- FHND6091
- Where
- 6 sites in China
- Volunteers
- 40 people
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Ovarian Cancer, Squamous Non-Small Cell Lung Cancer (NSCLC)
A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies
This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours.
- Conditions
- Ovarian Cancer, Squamous Non-Small Cell Lung Cancer (NSCLC), Synovial Sarcomas, Head and Neck Cancer
- Trial name
- NCT07613723
- Testing
- ZI-MA4-1 (TCR-NK cells), Cyclophosphamide, Fludarabine
- Where
- 2 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Zelluna Immunotherapy AS
Head and Neck Cancer Squamous Cell Carcinoma, Non-small Cell Lung Cancer
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment…
- Conditions
- Head and Neck Cancer Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Gastric Cancer, Esophageal Cancer
- Trial name
- NCT03621982
- Testing
- ADCT-301, Pembrolizumab
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 78 people
- Sponsor
- ADC Therapeutics S.A.
Advanced Solid Tumors
A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.
- Trial name
- NCT07093970
- Testing
- MRG006A
- Where
- 2 sites in China
- Volunteers
- 343 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Vulvovaginal Candidiasis (VVC)
ProF-001_Phase IIa
This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of ProF-001/Candiplus®…
- Trial name
- NCT03115073
- Testing
- Candiplus, Clotrimazole
- Where
- 3 sites in Austria
- Volunteers
- 84 people
- Sponsor
- ProFem GmbH
Influenza
Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine.
- Trial name
- NCT00349141
- Testing
- Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
- Where
- 3 sites in Austria, Singapore
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Healthy Subjects
A Study of SYHA1805 in Healthy Subjects
This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose of SYHA1805.
- Trial name
- NCT04977570
- Testing
- SYHA1805 tablets
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Carcinoma, Midline
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration…
- Trial name
- NCT01587703
- Testing
- GSK525762
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 196 people
- Sponsor
- GlaxoSmithKline
HIV Infection
Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine
The purpose of this study is to determine safety and immunogenicity (ability to induce an immune response) of a novel HIV vaccine based on adeno-associated virus (AAV)
- Trial name
- A001 (NCT00482027)
- Testing
- tgAAC09
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Healthy
Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
The objectives of this study are: To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
- Trial name
- hGH (NCT02146625)
- Testing
- CJ-40002
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Leukemia
Safety Study of CAT-8015 Immunotoxin in Patients With CLL, PLL or SLL With Advance Disease
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic…
- Trial name
- NCT00457860
- Testing
- Immunotoxin therapy, CAT-8015 immunotoxin, Biological therapy
- Where
- 4 sites in United States, Poland
- Volunteers
- 50 people
- Sponsor
- Cambridge Antibody Technology
Advanced Solid Tumors
Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713
To evaluate the safety and tolerability of the combination therapy of KN510 and KN713 and determine the MTD and RP2D in patients with advanced solid tumors.
- Trial name
- NCT06012708
- Testing
- KN510 60mg/day + KN713 60mg/day, KN510 120mg/day + KN713 60mg/day, KN510 120mg/day + KN713 90mg/day
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- New Cancer Cure-Bio Co.,Ltd.
Glioma, Glioma, Malignant
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422.
- Conditions
- Glioma, Glioma, Malignant, Glioma, Mixed, Glial Cell Tumors
- Trial name
- NCT04541225
- Testing
- NUV-422
- Where
- 12 sites in United States
- Volunteers
- 74 people
- Sponsor
- Nuvation Bio Inc.
Medical Oncology
Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors
Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY 94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with mesothelin-expressing predominantly epithelial…
- Trial name
- NCT02639091
- Testing
- BAY 94-9343, Pemetrexed, Cisplatin
- Where
- 6 sites in United States, Italy
- Volunteers
- 36 people
- Sponsor
- Bayer
Attention Deficit Disorder With Hyperactivity
A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder
The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD)
- Trial name
- NCT00326391
- Testing
- methylphenidate hydrochloride extended-release tablets
- Volunteers
- 229 people
- Sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Healthy Volunteers
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy…
- Trial name
- NCT00812825
- Testing
- PF-04171327, Prednisolone, PF-04171327 Tablet
- Where
- Belgium
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Pfizer
NALP3 Mutation
Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms
This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are…
- Trial name
- NCT00487708
- Testing
- canakinumab
- Where
- 10 sites in France, Germany and 3 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
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