Clinical trials: Phase I
Advanced Malignant Tumors
JSKN033 in Chinese Subjects with Advanced Malignant Tumors
This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
- Trial name
- NCT06770881
- Testing
- JSKN033
- Volunteers
- 430 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Pain
A Microneurography Study of NaV1.8 Inhibition in Healthy Adults
The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using…
- Trial name
- NCT06420765
- Testing
- VX-150, VX-548, VX-993
- Where
- United Kingdom
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Breast Neoplasms
A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse
The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three…
- Trial name
- MAGTRIVACSEIN (NCT02364492)
- Testing
- MAG-TN3 + AS15
- Where
- 5 sites in France
- Volunteers
- 20 people
- Sponsor
- Institut Pasteur
Ankylosing Spondylitis
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a long-term inflammatory disease that mainly affects the spine and sacroiliac joints, causing back pain and stiffness. Some patients do not respond well to existing treatments.
- Trial name
- NCT07915544
- Testing
- GKL-006Allo
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Beijing Gene Key Life Technology Co., Ltd
Naltrexone, Methylphenidate Abuse
Study for Naltrexone on the Abuse Potential of Methylphenidate
The current abuse liability study aims to assess the potential for co-administration of naltrexone (NTX) to reduce the abuse potential of methylphenidate (MPH).
- Trial name
- NCT03769064
- Testing
- Methylphenidate 60 mg, Treatment Phase Sequence 4213, Treatment Phase Sequence 2134
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Avekshan LLC
Renal Insufficiency
Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients
The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid…
- Trial name
- NCT01957657
- Testing
- BI 207127, faldaprevir
- Where
- Germany
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03948581
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Hematologic Neoplasms
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
The primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia.
- Trial name
- NCT00389428
- Testing
- CPX-351 (Cytarabine:Daunorubicin) Liposome Injection
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Jazz Pharmaceuticals
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
- Trial name
- NCT01074632
- Testing
- Lurasidone HCl
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Sumitomo Pharma America, Inc.
Multiple Myeloma, Myeloma
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36…
- Conditions
- Multiple Myeloma, Myeloma, Myeloma Multiple
- Trial name
- NCT05651932
- Testing
- Cohort A1 & A2: KTX-1001, Cohort B1 & B2: KTX-1001+Mezigdomide, Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)
- Where
- 29 sites in United States, Canada and 2 more
- Volunteers
- 165 people
- Sponsor
- K36 Therapeutics, Inc.
Relapsed/ Refractory Multiple Myeloma
Study Evaluating AMG 424 in Subjects With Multiple Myeloma
A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.
- Trial name
- NCT03445663
- Testing
- AMG 424
- Where
- 8 sites in United States, Australia
- Volunteers
- 27 people
- Sponsor
- Xencor, Inc.
ARDS (Acute Respiratory Distress Syndrome)
Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress…
- Trial name
- NCT07449572
- Testing
- HT31-1, Saline (0.9%, sterile, for infusion)
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- HTIC, Inc
Healthy
A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants
The purpose of this study is to assess the rate and extent of absorption of macitentan following administration of a single oral dose of macitentan formulated as final market image (FMI) (test), compared to macitentan as the…
- Trial name
- NCT04963439
- Testing
- Macitentan
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Actelion
Healthy
A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.
This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg…
- Trial name
- NCT01756781
- Testing
- Midazolam, PD-0332991
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
CD7+ T-ALL/LBL
Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic…
- Trial name
- R/R T-ALL/LBL (NCT07623681)
- Testing
- T cell injection targeting CD7 chimeric antigen receptor
- Where
- China
- Volunteers
- 12 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Intrahepatic Cholangiocarcinoma
HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study
A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-453 in Healthy Volunteers
- Trial name
- NCT05930119
- Testing
- HMPL-453, Rabeprazole
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Cancer, Graft-Versus-Host Disease
Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
- Trial name
- NCT00806728
- Testing
- MEDI-507
- Where
- 10 sites in United States
- Volunteers
- 17 people
- Sponsor
- MedImmune LLC
Advanced Solid Tumor
A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists.
- Trial name
- NCT01546428
- Testing
- INC280
- Where
- 2 sites in Japan
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Solid Neoplasms, Colorectal Neoplasms
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)
This study will be conducted to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.
- Conditions
- Solid Neoplasms, Colorectal Neoplasms, Gastrointestinal Tumors
- Trial name
- NCT03833700
- Testing
- E7386
- Where
- 8 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Eisai Co., Ltd.
Asthma
A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma
This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.
- Trial name
- NCT01195207
- Where
- 4 sites in Belgium, Germany and 1 more
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.
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