Clinical trials: Clinical Trial, Phase I
Healthy
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and…
- Trial name
- NCT03242239
- Testing
- ALT02, EU-licensed Herceptin, US-licensed Herceptin
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Alteogen, Inc.
Hepatitis C Virus
TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)
The purpose of this study is to investigate the effect of steady-state concentrations of erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a steady-state concentration of TMC435 (150 mg) on the…
- Trial name
- NCT01323257
- Testing
- erythromycin, Ritonavir, TMC435
- Where
- Belgium
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
- Trial name
- NCT07900945
- Testing
- CM551
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Healthy Participants, IBD (Inflammatory Bowel Disease)
A Phase I Study of HW201877 in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single…
- Trial name
- NCT07373457
- Testing
- HW201877 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Solid Tumor Malignancies
Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies
This protocol will examine the safety of intravenous administration of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C.
- Trial name
- NCT01118819
- Testing
- Clostridium novyi-NT spores
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- BioMed Valley Discoveries, Inc
Localized Adverse Reaction to Administration of Drug
Intralymphatic eASC Administration in Healthy Volunteers
The objective is to determine the safety, tolerability and feasibility of the inguinal intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)
- Trial name
- NCT01743222
- Testing
- eASC
- Where
- Spain
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tigenix S.A.U.
Neoplasms
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.
- Trial name
- NCT01682473
- Testing
- ZSTK474
- Where
- 2 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Zenyaku Kogyo Co., Ltd.
Myelodysplastic Syndromes
Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in…
- Trial name
- NCT02721875
- Testing
- Volasertib, Azacitidine
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Advanced Solid Tumors
A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs
This study will test BNT3219 (also known as PM1092) in adults with advanced solid tumors whose cancer has progressed after available standard treatments.
- Trial name
- NCT07893054
- Testing
- BNT3219
- Volunteers
- 207 people
- Sponsor
- BioNTech SE
Adhesions, Abdominal Cavity
A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
- Trial name
- A-PART (NCT00646412)
- Testing
- A-Part® Gel
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
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
Chronic Hepatitis C Infection
Therapeutic Hepatitis C Virus Vaccine
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients.
- Trial name
- NCT04318379
- Testing
- HCVax
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GeneCure Biotechnologies
Kidney Diseases
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
- Trial name
- NCT00807794
- Testing
- MEDI-507
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- MedImmune LLC
Healthy
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon®
- Trial name
- NCT02175394
- Testing
- Microgynon®, BI 1356
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Neutropenia, Breast Cancer
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide.
- Trial name
- NCT02527746
- Testing
- F-627, EC regimen
- Volunteers
- 18 people
- Sponsor
- EVIVE Biotechnology
Coronavirus
Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups.
- Trial name
- NCT04445194
- Testing
- Recombinant new coronavirus vaccine (CHO cell) low-dose group, Recombinant new coronavirus vaccine (CHO cells) high-dose group
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
HIV-1 Infection
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases.
- Trial name
- NCT01378156
- Testing
- JS7 plasmid DNA and MVA62B vaccine
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GeoVax, Inc.
Obesity
A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Participants
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.
- Trial name
- NCT07716241
- Testing
- HS-20136-2
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)
- Trial name
- NCT05934942
- Testing
- Yasmin®, BI 1358894
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Drug-Drug Interaction (DDI) Study for TQB3616
To evaluate the effect of itraconazole/rifampicin on the pharmacokinetics of TQB3616 capsules. To assess the safety of a single dose of oral TQB3616 capsules and in combination with itraconazole/rifampicin.
- Trial name
- NCT06662773
- Testing
- TQB3616 capsule + itraconazole, TQB3616 capsule + rifampicin
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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