Clinical trials: Phase I
Postmenopausal Women With Osteoporosis
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and…
- Trial name
- NCT03974100
- Testing
- GP2411, EU-Prolia (EU-authorized Prolia®)
- Where
- 42 sites in United States, Bulgaria and 4 more
- Volunteers
- 527 people
- Sponsor
- Sandoz
Chronic Hepatitis B
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects.
- Trial name
- NCT05569941
- Testing
- ABI-4334 Tablet
- Where
- New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Healthy Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
- Trial name
- NCT07222254
- Testing
- AZD0292
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Inflammation, Rheumatic Diseases
Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis
This study is intended to treat ankylosing spondylitis (AS). AS is a form of arthritis that primarily affects the spine. It is characterized by inflammation of the spinal joints that can lead to severe pain, and in more advanced…
- Trial name
- NCT04205851
- Testing
- KIN-1901
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Kinevant Sciences GmbH
Advanced Solid Tumors (Part A/B/C/D), Non-small Cell Lung Cancer (Part E)
A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549
This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors (Part A/B/C/D), Non-small Cell Lung Cancer (Part E), Melanoma (Part E), Squamous Cell Cancer of the Head and Neck (Part E)
- Trial name
- NCT02637531
- Testing
- IPI-549 (eganelisib), Nivolumab
- Where
- 11 sites in United States
- Volunteers
- 219 people
- Sponsor
- Infinity Pharmaceuticals, Inc.
Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma
A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab
This study is open to adults with advanced head and neck cancer, skin cancer, or non-small cell lung cancer. People can take part if previous treatments were not successful.
- Conditions
- Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT05068102
- Testing
- BI 765063, Ezabenlimab, [89Zr]Zr- BI 765063
- Where
- Netherlands
- Volunteers
- 14 people
- Sponsor
- Boehringer Ingelheim
Impaired Hepatic Function
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States.
- Trial name
- NCT02135302
- Testing
- eravacycline
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal…
- Trial name
- NCT03482453
- Testing
- TAK-788
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Advanced Cancer, Solid Tumors
A Phase 1, Open-Label, Dose-Escalation Study of NEV801, Administered to Patients With Advanced Cancers
This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial to be conducted in 2 sequential parts: Part A (Dose Escalation) in subjects with advanced malignancies Part B (Dose Confirmation) in…
- Trial name
- NCT02797795
- Testing
- NEV801
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Neovia Oncology Ltd.
Clear Cell Renal Cell Carcinoma, Cervical Carcinoma
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
- Conditions
- Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05795595
- Testing
- CTX131
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- CRISPR Therapeutics AG
Smoking
A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.
- Trial name
- NCT02633839
- Testing
- CVT-301, Carbidopa
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Acorda Therapeutics
Advanced Solid Tumors
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and…
- Trial name
- NCT01293630
- Testing
- Ombrabulin (AVE8062), Paclitaxel, Carboplatin
- Where
- 2 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Sanofi
Osteoarthritis of the Knee
A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain
Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee.
- Trial name
- NCT02184156
- Testing
- 4 mL injection of Ampion
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Ampio Pharmaceuticals. Inc.
ARDS, Human
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS
To evaluate the safety and efficacy of intravenous(IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles(EV), ExoFlo, as treatment for Acute Respiratory Distress Syndrome.
- Trial name
- EXIT-ARDS (NCT05127122)
- Testing
- Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles, Saline
- Sponsor
- Direct Biologics, LLC
Pancreatic Cancer
Safety and Efficacy Study of 90Y-hPAM4 at Different Doses
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
- Trial name
- NCT00597129
- Testing
- 90Y-hPAM4
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Gilead Sciences
Asthma
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of AZD9898
In this integrated, multi-part, Phase I study, the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of AZD9898 will be investigated.
- Trial name
- NCT03140072
- Testing
- AZD9898
- Where
- 2 sites in United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Tumors
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced…
- Trial name
- NCT00298675
- Testing
- BSI-201 (iniparib), irinotecan
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- Sanofi
Healthy Volunteers
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104…
- Trial name
- NCT04079101
- Testing
- BIIB104
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Subjects
Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.
- Trial name
- NCT02073812
- Testing
- RPX7009 and RPX2014
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Healthy Volunteers
A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.
- Trial name
- NCT02994381
- Testing
- RPC1063
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Celgene
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.