Clinical trials: Phase I
Healthy Male Volunteers
Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral…
- Trial name
- NCT05475834
- Testing
- SIM0417
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
NSCLC, Stage I
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm.
- Trial name
- NCT04317534
- Testing
- Pembrolizumab
- Where
- 13 sites in United States
- Volunteers
- 244 people
- Sponsor
- Greg Durm, MD
Healthy
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.
- Trial name
- NCT02431364
- Testing
- Verdinexor
- Where
- Australia
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Karyopharm Therapeutics Inc
KRAS G12D Mutation, Advanced Solid Cancer
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
- Trial name
- NCT07023731
- Testing
- ARV-806
- Where
- 14 sites in United States
- Volunteers
- 76 people
- Sponsor
- Arvinas Inc.
Advanced Solid Tumors
Phase 1, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors
CD40, a member of the Tumor Necrosis Factor receptor superfamily, is expressed on many tumor types, including melanoma, prostate, colon, breast, renal, pancreatic, and nonsmall cell lung cancers.
- Trial name
- NCT02225002
- Testing
- CP-870,893
- Where
- United States
- Sponsor
- Abramson Cancer Center at Penn Medicine
Influenza A Virus, H7N9 Subtype
Evaluating the Safety and Immunogenicity of a H7N9 Vaccine for the Prevention of Influenza H7N9 Disease in Adults 50 to 70 Years Old
H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that affected many older adults. This study will evaluate the safety of and immune response to a live attenuated H7N9 vaccine in adults 50…
- Trial name
- NCT02274545
- Testing
- H7N9 Anhui 2013/AA ca, Inactivated subvirion H7N9 vaccine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Safety Issues
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
The purpose of this study was to determine the safety and tolerability of PH100, a purified phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds 8,8'-bieckol, dieckol, and…
- Trial name
- NCT04335045
- Testing
- PH100 100mg, PH100 200mg, PH100 400mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Phloronol Inc.
Ovarian Neoplasms, Endometrial Neoplasms
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors.
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung
- Trial name
- NCT06400472
- Testing
- Sofe-M, bevacizumab, carboplatin
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 575 people
- Sponsor
- Eli Lilly and Company
Skin and Soft Tissue Infections, Methicillin-resistant Staphylococcus Aureus
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site.
- Trial name
- NCT00989872
- Testing
- EDP-322
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Locally Advanced or Metastatic Solid Tumors
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or…
- Trial name
- NCT06307795
- Testing
- ANS014004
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 63 people
- Sponsor
- Avistone Biotechnology Co., Ltd.
Myelofibrosis
Panobinostat and Ruxolitinib In MyElofibrosis (PRIME Trial)
This is a single-center, single arm, dose finding study to assess safety and tolerability of the oral combination of Panobinostat and Ruxolitinib in patients with myelofibrosis (MF) in chronic and accelerated phase.
- Trial name
- PRIME (NCT01693601)
- Testing
- Panobinostat, Ruxolitinib
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- John Mascarenhas
High-grade Squamous Intraepithelial Lesion (HSIL)
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL
This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.
- Trial name
- NCT06276101
- Testing
- NWRD08 administered by electroporation
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Newish Technology (Beijing) Co., Ltd.
Cerebral Palsy
A Study of UCB and MSCs in Children With CP: ACCeNT-CP
The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal…
- Trial name
- ACCeNT-CP (NCT03473301)
- Testing
- Infusion of allogeneic umbilical cord blood, Infusion of MSCs
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Joanne Kurtzberg, MD
Prostate Cancer
Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.
- Trial name
- NCT00003819
- Testing
- QS21, TF(c)-KLH conjugate vaccine, Thomsen-Friedenreich antigen
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Angina Pectoris, Myocardial Infarction
EndocardialVascularEndothelialGrowth Factor D(VEGF-D)Gene Therapy for the Treatment of Severe Coronary Heart Disease
The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus VEGF-D gene therapy in patients with severe coronary heart disease.
- Trial name
- KAT301 (NCT01002430)
- Testing
- VEGF-D gene transfer
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Kuopio University Hospital
Multiple Myeloma
Study of bb21217 in Multiple Myeloma
Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).
- Trial name
- NCT03274219
- Testing
- bb21217
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- 2seventy bio
Solid Tumors
Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial
The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical…
- Trial name
- NCT01593228
- Testing
- Iniparib (SAR240550/BSI-201), Carboplatin, Doxorubicin HCL liposome injection
- Where
- 32 sites in United States, Belgium and 2 more
- Volunteers
- 37 people
- Sponsor
- Sanofi
Insulin Resistance
A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin…
- Trial name
- NCT00991107
- Testing
- HE3286
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Harbor Therapeutics
Lung Neoplasms
Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial
This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided…
- Trial name
- NCT03325907
- Testing
- navigational template
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Shigellosis, Bacillary Dysentery
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
- Trial name
- NCT02797236
- Testing
- SF2a-TT15 vaccine, SF2a-TT15 vaccine + adjuvant
- Where
- Israel
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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