Clinical trials: Phase I
Hemophilia A
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Primary objective To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives To characterize additional pharmacokinetic…
- Trial name
- NCT05042440
- Testing
- Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol
- Where
- Bulgaria
- Volunteers
- 13 people
- Sponsor
- Sanofi
Mesial Temporal Lobe Epilepsy
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).
- Trial name
- GenTLE (NCT06063850)
- Testing
- AAV9-hSyn1-miGRIK2
- Where
- 18 sites in United States
- Volunteers
- 12 people
- Sponsor
- UniQure Biopharma B.V.
Healthy
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3.
- Trial name
- NCT01468558
- Testing
- MAP0004, IV DHE, Ketoconazole
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allergan
Metastatic Solid Tumor
QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors
This is a two-part, open-label phase 1 study to evaluate safety and preliminary efficacy of M-CENK Suspension for Infusion, Cryopreserved, and N-803 for subcutaneous administration in subjects with locally advanced or metastatic…
- Trial name
- NCT04898543
- Testing
- M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B), N-803 (Cohort 2 part B), Apheresis collection of MNCs (part A)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
Acne Vulgaris
W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne
This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben.
- Trial name
- NCT01132443
- Testing
- Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,
- Volunteers
- 72 people
- Sponsor
- Stiefel, a GSK Company
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
Metastatic Renal Cell Carcinoma, Metastatic Malignant Melanoma
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
- Trial name
- NCT00625768
- Testing
- AS1409
- Where
- 4 sites in New Zealand, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Antisoma Research
Bacterial Infections
A Safety and PK Study of IV Eravacycline
This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection.
- Trial name
- NCT03696550
- Testing
- Eravacycline (TP-434)
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy…
- Trial name
- NCT05807490
- Testing
- PF-07328948
- Where
- 2 sites in United States, Belgium
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Pfizer
Inflammatory Bowel Diseases (IBD)
BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with relapsed and/or refractory…
- Trial name
- NCT07544160
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T
- Where
- China
- Volunteers
- 18 people
- Sponsor
- iCell Gene Therapeutics
Influenza Immunization
Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the…
- Trial name
- NCT06727058
- Testing
- Pandemic flu H5 mRNA vaccine
- Where
- 14 sites in United States
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gastrointestinal Stromal Tumors
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients.
- Trial name
- NCT01396148
- Testing
- sunitinib malate dose escalation, sunitinib malate
- Where
- 9 sites in United States, Czechia and 1 more
- Volunteers
- 6 people
- Sponsor
- Pfizer
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Extensive-Stage Small Cell Lung Cancer
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the…
- Trial name
- NCT04404543
- Testing
- SYHA1807
- Volunteers
- 71 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Lymphoma, Lymphoma, Mantle-Cell
Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma
This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects
- Conditions
- Lymphoma, Lymphoma, Mantle-Cell, Neoplasms by Histologic Type, Neoplasms
- Trial name
- NCT05155215
- Testing
- IM19 CAR-T cells, Cyclophosphamide, Fludarabine
- Volunteers
- 68 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Spinal Cord Injury
Safety Study of GRNOPC1 in Spinal Cord Injury
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).
- Trial name
- NCT01217008
- Testing
- GRNOPC1
- Where
- 7 sites in United States
- Volunteers
- 5 people
- Sponsor
- Lineage Cell Therapeutics, Inc.
Influenza
Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population.
- Trial name
- NCT00517517
- Testing
- Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
- Where
- 4 sites in Hong Kong, Singapore
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Solid Tumours
Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in development for the treatment of solid tumours over-expressing CA IX.
- Trial name
- NCT02215850
- Testing
- SLC-0111
- Where
- 3 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Welichem Biotech Inc.
Non-Small Cell Lung Cancer
Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients
The main objective of this study is to evaluate the safety and tolerability of BPI-15086.
- Trial name
- NCT02914990
- Testing
- BPI-15086
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Phenylketonuria
GenSci144 Tablets Phase I Clinical Trial
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels.
- Trial name
- NCT07685210
- Testing
- GenSci144 tablets
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.