Clinical trials: Dose Escalation and Safety
Infections, Bacterial
A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects
The primary objectives of this study are to assess the safety, tolerability and pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration.
- Trial name
- NCT01818011
- Testing
- GSK1322322 Initial fit for purpose tablets, GSK1322322 over granulated tablets, GSK1322322 intended commercial tablets
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumor
Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
This is a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor…
- Trial name
- NCT05101109
- Testing
- ABL501
- Where
- 4 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- ABL Bio, Inc.
Healthy Subjects
Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules
This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and…
- Trial name
- NCT06279533
- Testing
- LV232
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Hemophilia
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B
This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia…
- Trial name
- rhFVIIa (NCT01708564)
- Testing
- rhFVIIa
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 15 people
- Sponsor
- rEVO Biologics
Healthy Volunteer, Pharmacokinetic Study
A Study of Ralinepag in Healthy Chinese Adult Subjects
A Phase 1 Open-label, Non-randomized, Single Ascending Dose Escalation Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Ralinepag Extended Release (XR) Tablet Formulation In Healthy Chinese Subjects.
- Trial name
- NCT04613999
- Testing
- Ralinepag
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Everstar Medicines (Shanghai) Limited
Nonexudative Age-related Macular Degeneration
Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration
Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.
- Trial name
- NCT01922128
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MacuCLEAR, Inc.
Pulmonary Arterial Hypertension
Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult…
- Trial name
- NCT04903730
- Testing
- AER-901 Solution for Nebulization
- Where
- Australia
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Aerami Therapeutics
Hantavirus Pulmonary Infection, Immunisation
Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03682107
- Testing
- Andes virus DNA vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non…
- Conditions
- Head and Neck Carcinoma, Adenoid Cystic Carcinoma, Lung Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT03556228
- Testing
- VMD-928 100 mg Tablet, VMD-928 Tablet and Pembrolizumab (200 mg)
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 242 people
- Sponsor
- VM Oncology, LLC
HRD-negative Epithelial Ovarian Cancer
A Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Study Participants With HRD-negative Epithelial Ovarian Cancer
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated exploratory study designed to evaluate the safety, tolerability and preliminary efficacy of tumor neoantigen-pulsed autologous dendritic…
- Trial name
- YS247 (NCT07455071)
- Testing
- Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)
- Volunteers
- 9 people
- Sponsor
- Peking University Third Hospital
Metastatic Colorectal Cancer
A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with FOLFIRI in…
- Trial name
- NCT02453464
- Testing
- Sevacizumab, Irinotecan, 5-FU
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Opioid Use Disorder
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD).
- Trial name
- NCT06538558
- Testing
- Tezampanel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Proniras Corporation
Tumors, Lymphoma
Safety Study of Ridaforolimus in Patients With Advanced, Refractory or Recurrent Malignancies (MK-8669-001 AM5)(COMPLETED)
Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of ridaforolimus in patients with refractory or recurrent malignancies, including myeloma and lymphoma.
- Conditions
- Tumors, Lymphoma, Multiple Myeloma
- Trial name
- NCT00060632
- Testing
- ridaforolimus
- Volunteers
- 46 people
- Sponsor
- Merck Sharp & Dohme LLC
HEPATITIS B CHRONIC
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
- Trial name
- ELIMINATE-B (NCT06680232)
- Testing
- PBGENE-HBV
- Where
- 7 sites in United States, France and 4 more
- Volunteers
- 45 people
- Sponsor
- Precision BioSciences, Inc.
Anthrax
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
- Trial name
- NCT02655549
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Pfenex, Inc
Huntington Disease
The Safety and Tolerability Study With ER2001 Intravenous Injection in Adults With Early Manifest Huntington's Disease
This is an open label, dose escalation clinic trial of ER2001 intravenous injection to evaluate safety, tolerability and pharmacokinetics of ascending single and multiple doses of intravenously administered ER2001 in patients…
- Trial name
- NCT06024265
- Testing
- ER2001 injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- ExoRNA Bioscience
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08065010) for possible treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
- Trial name
- NCT07235163
- Testing
- PF-08065010
- Where
- Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Lung Non-Small Cell Carcinoma, Locally Advanced Lung Non-Small Cell Carcinoma
Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer
This phase Ib trial tests the side effects and best dose of minnelide when given together with osimertinib for the treatment of non-small cell lung cancer that has spread to other places in the body (advanced) and has a change…
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Locally Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8
- Trial name
- NCT05166616
- Testing
- Biopsy, Osimertinib, Triptolide Analog
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- City of Hope Medical Center
Non Small Cell Lung Cancer, Advanced Solid Tumor
TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and/or relapsed or refractory hematological malignancies
- Conditions
- Non Small Cell Lung Cancer, Advanced Solid Tumor, Hematologic Malignancy
- Trial name
- NCT06484816
- Testing
- TGRX-1942
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shenzhen TargetRx Co., Ltd.
HIV Infections
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants.
- Trial name
- NCT06033547
- Testing
- Cabotegravir Formulation F, Cabotegravir Formulation G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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