Clinical trials: Dose Escalation and Safety
Ulcerative Colitis, Autoimmune Diseases
Autologous Ex Vivo Expanded Regulatory T Cells in Ulcerative Colitis
Together with Crohn's disease (CD), ulcerative colitis (UC) is one of the major forms of inflammatory bowel diseases (IBD).Currently, no curative therapy is available, since the pathophysiology of this disease is incompletely…
- Trial name
- NCT04691232
- Testing
- Regulatory T cells
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Inflammatory Bowel Disease
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085…
- Trial name
- NCT06175949
- Testing
- HRS-7085 Tablets, HRS-7085 simulant
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Malaria, Plasmodium Falciparum Malaria
Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults
This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P.
- Trial name
- NCT02132299
- Testing
- PfSPZ Vaccine, PfSPZ Challenge
- Where
- Tanzania
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Rheumatoid Arthritis
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period.
- Trial name
- NCT01253226
- Testing
- LY2127399 (Tabalumab)
- Where
- 10 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Healthy Volunteer
Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of single- and multiple-ascending oral doses of BIIB095 in healthy participants.
- Trial name
- NCT03454126
- Testing
- BIIB095
- Where
- 2 sites in United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Advanced Cancer, Refractory Cancer
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are…
- Conditions
- Advanced Cancer, Refractory Cancer, Tumor Gastric
- Trial name
- NCT04861987
- Testing
- PCS6422 and capecitabine
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Processa Pharmaceuticals
Alzheimer's Disease
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006…
- Trial name
- NCT05074498
- Testing
- TB006
- Where
- 18 sites in United States
- Volunteers
- 154 people
- Sponsor
- TrueBinding, Inc.
Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC)
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer.
- Conditions
- Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT06878248
- Testing
- Two Component Product CLBR001 + ABBV-461
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Calibr, a division of Scripps Research
Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or…
- Trial name
- NCT02457793
- Testing
- Cobimetinib, GDC-0994
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Neoplasms
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies
Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients…
- Trial name
- NCT01188252
- Testing
- Roniciclib (BAY1000394)
- Where
- 9 sites in United States, France and 1 more
- Volunteers
- 112 people
- Sponsor
- Bayer
Multiple Myeloma
Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics and initial efficacy of AO-176 as monotherapy and in combination with dexamethasone and bortezomib in adults with…
- Trial name
- NCT04445701
- Testing
- AO-176, AO-176 + Dex, AO-176 + Dex + Bort
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Arch Oncology
Solid Tumors, Adult
PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy…
- Trial name
- NCT06897228
- Testing
- PANK-003 cell injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shenzhen Celconta Life Science Co., Ltd.
Influenza A Virus Infection, Influenza A
The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac
The present clinical phase I study designed to examine the safety, reactogenicity and immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy volunteers after a single dose in the three groups…
- Conditions
- Influenza A Virus Infection, Influenza A, Influenza Epidemic, Influenza H5N1
- Trial name
- NCT03651544
- Testing
- GamFluVac
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Acute Myeloid Leukemia
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia.
- Trial name
- NCT03671564
- Testing
- Milademetan
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
COVID-19
Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine
This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety…
- Trial name
- COVID-19-101 (NCT04497298)
- Testing
- Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose, Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose, One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose
- Where
- 2 sites in Belgium, France
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Advanced Cancer, Solid Tumors
Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies
Primary Objective: -To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.
- Trial name
- NCT00629200
- Testing
- Sodium Stibogluconate, Interferon Alpha-2b
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- M.D. Anderson Cancer Center
Cancer
Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors
The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing…
- Trial name
- NCT00528047
- Testing
- PRLX 93936
- Where
- 3 sites in United States
- Volunteers
- 37 people
- Sponsor
- Prolexys Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
A Study of KK2269 in Adult Participants With Solid Tumors
This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT06266299
- Testing
- KK2269, Docetaxel
- Where
- 32 sites in United States, Japan
- Volunteers
- 83 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Chronic Hepatitis B
A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection
This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016…
- Trial name
- NCT05017116
- Testing
- RBD1016, Entecavir
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Suzhou Ribo Life Science Co. Ltd.
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