Clinical trials: Dose Escalation and Safety
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
Healthy Volunteers
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TB-840 in Healthy Subjects
TB-840(Agonist of RORα) is a candidate for NASH treatment that activates RORα(Retinoid-related orphan receptor) and its target validation for RORα and potential as a NASH treatment.
- Trial name
- NCT05045534
- Where
- South Korea
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Therasid Bioscience
Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).
This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with…
- Trial name
- NCT07684560
- Testing
- Alpha-0261
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaMol Science Ltd. (Shanghai)
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and…
- Trial name
- TEXT-TKR (NCT03251482)
- Testing
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, JNJ-64179375 1.2 mg/kg
- Where
- 103 sites in United States, Argentina and 14 more
- Volunteers
- 308 people
- Sponsor
- Janssen Research & Development, LLC
Cough
A Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HS-10383
This study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 in healthy subjects using a randomized, double blind, placebo controlled, single center study design.
- Trial name
- NCT06092983
- Testing
- HS-10383
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Advanced Solid Tumors
A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors
This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic…
- Trial name
- NCT04911894
- Testing
- IBI321
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hepatitis C
Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C
The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to…
- Trial name
- PLUS (NCT00593151)
- Testing
- Locteron (controlled-release interferon alpha 2b), pegylated IFNa2b
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- Biolex Therapeutics, Inc.
Inflammation, Rheumatoid Arthritis
Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the…
- Trial name
- NCT01370902
- Testing
- NNC 0141-0000-0100
- Where
- Germany
- Volunteers
- 92 people
- Sponsor
- Innate Pharma
HIV
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it.
- Trial name
- NCT05627258
- Testing
- VRC-HIVMAB0115-00-AB
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
B-cell Non Hodgkin's Lymphoma
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
- Trial name
- NCT02206308
- Testing
- Chimeric anti-CD20 monoclonal antibody
- Volunteers
- 15 people
- Sponsor
- Sinocelltech Ltd.
Neoplasms
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
- Trial name
- NCT05712889
- Testing
- VIP236 (Q3W), VIP236 (Q2W)
- Where
- 6 sites in United States, Australia
- Volunteers
- 29 people
- Sponsor
- Vincerx Pharma, Inc.
Non-alcoholic Steatohepatitis (NASH)
FTIH of ECC4703 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL
- Trial name
- NCT05552274
- Testing
- ECC4703
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Eccogene
Female Sexual Health
A Open-Label, Within-Subject Dose-Escalation Study to Evaluate the Clinical Safety and Pharmacokinetic Profile of a Topical Sildenafil Cream (5% w/w), in Healthy Postmenopausal Women
This is a Phase 1, single center, open-label, within-subject dose-escalation study evaluating the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women.
- Trial name
- NCT02364882
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Strategic Science & Technologies, LLC
Solid Tumors
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.
- Trial name
- NCT00882180
- Testing
- ALN-VSP02
- Where
- 10 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- Alnylam Pharmaceuticals
Neoplasms
Safety Study of rhuMAb 2C4 to Treat Advanced Solid Tumors
The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without…
- Trial name
- NCT00027027
- Testing
- rhuMAb 2C4
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Genentech, Inc.
Health, Health Adult Subjects
DBM-1152A Inhalation Solution in Chinese Healthy Subjects
This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A…
- Trial name
- NCT07447141
- Testing
- DBM-1152A Inhalation Solution
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
Malignant Neoplasm
A Safety and Pharmacokinetic Study of NBM-BMX Administered Orally to Patients With Advanced Cancer
NBM-BMX is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by NatureWise. NBM-BMX is a histone deacetylase (HDAC) inhibitor and has been shown to be particularly active against HDAC8.
- Trial name
- NCT03726294
- Testing
- NBM-BMX softgel capsules
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- NatureWise Biotech & Medicals Corporation
Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS)
A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma
SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B.
- Conditions
- Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS), Osteosarcoma, Advanced
- Trial name
- NCT07801222
- Testing
- SOT106
- Where
- Moldova
- Volunteers
- 70 people
- Sponsor
- SOTIO Biotech a.s.
Diffuse Large B-Cell Lymphoma, B-cell Malignancies
A Study Investigating the Safety and How the Trispecific T-Cell Engaging Antibody BG-T0920 Works in Adults With Diffuse Large B-cell Lymphoma (DLBCL) and Other Aggressive B-Cell Malignancies
The purpose of this study is to test the safety and tolerability of BG-T0920 and to identify the recommended dose and dosing schedule (including dose levels and timing) that can be taken without having serious side effects in…
- Trial name
- NCT07887646
- Testing
- BG-T0920
- Volunteers
- 70 people
- Sponsor
- BeOne Medicines
SHANK3 Haploinsufficiency, Phelan-McDermid Syndrome
Long-Term Follow-Up Study for RB001 Gene Therapy Study in Children With SHANK3-related Phelan McDermid Syndrome (PMS)
This is a long-term follow-up study of participants in the RB001-101 gene replacement therapy clinical trial for Children With SHANK3-related Phelan-McDermid Syndrome (PMS).
- Trial name
- RB001-101-LTFU (NCT07690527)
- Testing
- RB001
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Peking University First Hospital
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