Clinical trials: Phase I
Postmenopausal Osteoporosis
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of…
- Trial name
- NCT03925051
- Testing
- Prolia®, CMAB807
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Lower Extremity Chronic Venous Ulcers
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers
The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
- Trial name
- ENZ-DER-002-IL (NCT00485329)
- Testing
- Papain
- Where
- 3 sites in Israel
- Volunteers
- 48 people
- Sponsor
- EnzySurge
Healthy Volunteers
Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
Study of a drug drug interaction between Paroxetine and PF-00299804.
- Trial name
- NCT01318031
- Testing
- Period 1, Period 2
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose.
- Trial name
- NCT03912831
- Testing
- KITE-439, Cyclophosphamide, Fludarabine
- Where
- 9 sites in United States
- Volunteers
- 8 people
- Sponsor
- Gilead Sciences
COVID-19, Coronavirus Infections
Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant
VBI-2901e is an investigational vaccine candidate that uses enveloped virus-like particles (eVLPs) to express the spike proteins of three coronaviruses: SARS-CoV-2 (the virus that causes COVID-19 disease), SARS-CoV-1 and…
- Trial name
- NCT05614245
- Testing
- VBI-2901e
- Where
- 4 sites in Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Colon Cancer, Metastatic Colon Cancer
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors…
- Trial name
- NCT05848739
- Testing
- ST316, FOLFIRI regimen & bevacizumab, Fruquintinib
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- Sapience Therapeutics
Ulcerative Colitis
Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects
This study evaluates the safety and tolerability of TOP1288 oral single ascending and multiple doses in healthy subjects.
- Trial name
- NCT03071081
- Testing
- TOP1288
- Where
- United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Topivert Pharma Ltd
Advanced Solid Tumor
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients.
- Trial name
- NCT05341570
- Testing
- BPI-21668
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Resistant or Refractory Solid Tumors
Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors
This is a multi-center, open-label, dose-escalation, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or…
- Trial name
- NCT04686383
- Testing
- CAL056 mesylate
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 17 people
- Sponsor
- Calgent Biotechnology Co., Ltd
Healthy Subjects
Phase I Study to Evaluate rhTPO in Healthy Caucasian Volunteers
This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in…
- Trial name
- NCT06630494
- Testing
- Recombinant human thrombopoietin for injection (rhTPO)
- Where
- Australia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- 3SBIO AU PTY LTD
Dyslipidemias, Non-Alcoholic Fatty Liver Disease
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with…
- Trial name
- NCT06007651
- Testing
- LY3885125
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Eli Lilly and Company
Multiple Sclerosis, CAR T Cell Therapy
MB-CART2019.1 in Refractory Multiple Sclerosis
The goal of this trial is to assess the feasibility, safety and preliminary efficacy of MB-CART2019.1 in patients with active refractory primary and secondary progressive MS.
- Trial name
- NCT07178431
- Testing
- MB-CART2019.1
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Miltenyi Biomedicine GmbH
Non Small Cell Lung Cancer
XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
The trial is divided into two parts, one is dose escalation phase, the second one is dose expansion phase. For dose escalation phase, the main purpose is to evaluate safety and tolerability of XZP-5809-TT1 tablets after treatment…
- Trial name
- NCT04622072
- Testing
- XZP-5809-TT1 Tablet
- Where
- 5 sites in China
- Volunteers
- 21 people
- Sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
Acute Ischemic Stroke
Study to Assess PK, Safety and Tolerability Early in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses.
- Trial name
- NCT06388772
- Testing
- QHRD106 Injection
- Where
- China
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Changzhou Qianhong Bio-pharma Co., Ltd.
Immune System Diseases
A Study of Subcutaneous KY1005 in Healthy Volunteers
Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.
- Trial name
- NCT04449939
- Testing
- KY1005
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Kymab Limited
Healthy Volunteers
A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.
- Trial name
- NCT03434977
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Hypertension
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy Volunteers
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1015" and co-administration of "BR1015-1" and "BR1015-2" under fasting conditions in healthy volunteers
- Trial name
- NCT06008028
- Testing
- BR1015, BR1015-1, BR1015-2
- Where
- South Korea
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Respiratory Syncytial Virus Immunization
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate…
- Trial name
- NCT05639894
- Testing
- RSV vaccine candidate
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 865 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Mantle Cell Lymphoma
Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma
The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody followed by CHOP and to see what effects it has on patients with previously untreated mantel cell lymphoma.
- Trial name
- NCT00022945
- Testing
- Iodine-131 Anti-B1 Antibody, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP)
- Where
- 3 sites in United States
- Sponsor
- Corixa Corporation
Obesity
A Study to Learn How Different Amounts of the Study Medicine Called PF-08642534 Are Tolerated and Act in the Body of People Who Have Obesity
This study will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity…
- Trial name
- NCT07731139
- Testing
- PF-08642534
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Pfizer
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