Clinical trials: Dose Escalation and Safety
Atopic Dermatitis
Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.
- Trial name
- NCT05932888
- Testing
- QLM3003
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Advanced Solid Tumors
Study of FID-022 in Participants With Advanced Solid Tumors
The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.
- Trial name
- NCT06694480
- Testing
- FID-022
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Fulgent Pharma LLC.
Fallopian Tube Cancer, Ovarian Cancer
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and…
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
- Trial name
- NCT00753480
- Testing
- D4064A
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Genentech, Inc.
Immune Thrombocytopenia Purpura
Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)
The primary objectives of this study are to assess the safety and tolerability of single rising doses of MK-8723 in healthy adult participants and adult participants with chronic immune thrombocytopenia purpura (ITP) and to…
- Trial name
- NCT01963260
- Testing
- MK-8723
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Sepsis Associated Disseminated Intravascular Coagulation (DIC)
A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.
This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body when given at different…
- Trial name
- NCT07176728
- Testing
- BAY 3389934
- Where
- 2 sites in Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Hepatitis C (HCV)
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that…
- Trial name
- NCT00807001
- Testing
- IDX184
- Volunteers
- 41 people
- Sponsor
- Merck Sharp & Dohme LLC
Parkinson's Disease
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers. Objectives are to determine: 1.
- Trial name
- NCT01486628
- Testing
- ND0612
- Where
- Israel
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- NeuroDerm Ltd.
Refractory Solid Tumors
Safety and Preliminary Efficacy of BNA035 in Patients With Advanced Solid Tumors
The purpose of the study is to evaluate the safety and tolerability of BNA035 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each…
- Trial name
- NCT05150457
- Testing
- BNA035
- Where
- 3 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Binacea Pharma, Inc.
Autoimmune Disease
Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy participants.
- Trial name
- NCT05894707
- Testing
- SCT650C
- Where
- 3 sites in Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sinocelltech Ltd.
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
Healthy Participants
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants
This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect, and drug-drug interaction study of ACP-196 in healthy participants.
- Trial name
- NCT04901923
- Testing
- ACP-196, Itraconazole
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Solid Tumors, Non-Small Cell Lung Cancer
Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
This is a phase 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with…
- Conditions
- Solid Tumors, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
- Trial name
- NCT07558200
- Testing
- Intervention1:FXB0871, Intervention2:FXB0871, Intervention3:FXB0871
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Cancer, Solid Tumors
Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas
The purpose of this study is to determine the safety profile and the maximum dose of Debio 1143 (AT-406) that can be given to humans.
- Conditions
- Cancer, Solid Tumors, Lymphoma, Malignancy
- Trial name
- NCT01078649
- Testing
- Debio 1143 (AT-406)
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Debiopharm International SA
Diabetes Mellitus
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251…
- Trial name
- NCT02106585
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Shionogi Inc.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer…
- Trial name
- TulmiSTAR-02 (NCT07190300)
- Testing
- Tulmimetostat, Darolutamide, Abiraterone
- Where
- 31 sites in United States, Australia and 12 more
- Volunteers
- 181 people
- Sponsor
- Novartis Pharmaceuticals
Liver Disease
A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency
This is a prospective dose escalation study of the administration of adult human stem cells in patients with end stage liver failure.
- Trial name
- NCT00655707
- Testing
- Autologous Expanded CD34+ Haemopoietic cells
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
Dermatitis, Atopic
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD)
This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis.
- Trial name
- NCT04220411
- Testing
- AR100DP1
- Where
- Taiwan
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Arjil Pharmaceuticals LLC
Recurrent or Metastatic Solid Tumors
A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.
- Trial name
- NCT02221960
- Testing
- MEDI6383, MEDI6383 and MEDI4736
- Where
- 8 sites in United States, Australia
- Volunteers
- 39 people
- Sponsor
- MedImmune LLC
TB Multi-drug Resistant
Dose Escalation Study of SQ109 in Healthy Adult Volunteers
The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and…
- Trial name
- NCT00866190
- Testing
- SQ109
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Colorectal Cancer, Pancreatic Cancer
Evaluation of Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With CSF-1R TKI (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers
Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality.
- Conditions
- Colorectal Cancer, Pancreatic Cancer, Metastatic Cancer, Advanced Cancer
- Trial name
- MEDIPLEX (NCT02777710)
- Testing
- Pexidartinib, Durvalumab
- Where
- 2 sites in France
- Volunteers
- 48 people
- Sponsor
- Centre Leon Berard
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