Clinical trials: Dose Escalation and Safety
Moderate to Severe Atopic Dermatitis
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
The study will be conducted to evaluate the safety and tolerability of SHR-1819 injection and describe the PK/PD/ADA and explore the clinical efficacy.
- Trial name
- NCT05197023
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Solid Cancers
A Study of the Safety and Pharmacokinetics of MINT1526A, Administered Intravenously As a Single Agent and in Combination With Bevacizumab to Patients With Advanced Solid Tumors
This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A administered alone and in combination with bevacizumab by IV infusion every 3 weeks to patients with advanced solid tumors for whom standard…
- Trial name
- NCT01139723
- Testing
- MINT1526A, bevacizumab
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Genentech, Inc.
Advanced Solid Tumors
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα)…
- Trial name
- NCT06804824
- Testing
- VVD-159642, Sotorasib, Trametinib
- Where
- 9 sites in United States, Australia
- Volunteers
- 220 people
- Sponsor
- Vividion Therapeutics, Inc.
Severe Sepsis, Septic Shock
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773.
- Trial name
- NCT01144624
- Testing
- AZD9773
- Where
- 7 sites in Japan
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Bacterial Infections
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects.
- Trial name
- NCT02955459
- Testing
- VNRX-5133
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Venatorx Pharmaceuticals, Inc.
Melanoma
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination…
- Trial name
- NCT01489059
- Testing
- BMS-982470 (recombinant interleukin-21), Ipilimumab
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 42 people
- Sponsor
- Bristol-Myers Squibb
Healthy
Single Ascending Oral Dose Phase I Study With Px-102
The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.
- Trial name
- NCT01998659
- Testing
- Px-102
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Phenex Pharmaceuticals AG
Small Cell Lung Cancer, Uveal Melanoma
A Study of PLX2853 in Advanced Malignancies.
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with advanced malignancies.
- Conditions
- Small Cell Lung Cancer, Uveal Melanoma, Ovarian Clear Cell Carcinoma, Non-Hodgkin Lymphoma
- Trial name
- NCT03297424
- Testing
- PLX2853
- Where
- 5 sites in United States
- Volunteers
- 49 people
- Sponsor
- Opna Bio LLC
Non-Alcoholic Steatohepatitis (NASH)
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.
- Trial name
- NCT01899859
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Galectin Therapeutics Inc.
Healthy Volunteers
Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects
The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.
- Trial name
- NCT01636141
- Testing
- OLT1177 Gel
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Olatec Therapeutics, Inc.
Solid Tumor, Colorectal Cancer
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
- Conditions
- Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer, Rectosigmoid Junction Cancer
- Trial name
- NCT05943041
- Testing
- GB104(Level 1), GB104(Level 2), GB104(Level 3)
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- GILongevity
Myelodysplastic Syndrome
Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (< 20% blasts in bone marrow, peripheral blood, or…
- Trial name
- NCT01980056
- Testing
- Vosaroxin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Weill Medical College of Cornell University
Rhegmatogenous Retinal Detachment - Macula Off
A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
The purpose of this study is to evaluate the safety and tolerability of ONL1204 in participants with Macula-off, Rhegmatogenous Retinal Detachment (RRD).
- Trial name
- NCT03780972
- Testing
- ONL1204, Intravitreal Injection, Collection of ocular fluids
- Where
- 4 sites in Australia
- Volunteers
- 14 people
- Sponsor
- ONL Therapeutics
Atopic Dermatitis
Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.
The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.
- Trial name
- NCT06553287
- Testing
- LNK01004 ointment 0.3%, LNK01004 ointment 1.0%, LNK01004 ointment 1.5%
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Lynk Pharmaceuticals Co., Ltd
Radiation-Induced Parotid Gland Hypofunction, Xerostomia Due to Radiotherapy
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and…
- Conditions
- Radiation-Induced Parotid Gland Hypofunction, Xerostomia Due to Radiotherapy, Head and Neck Cancer
- Trial name
- NCT04043104
- Testing
- AAV2hAQP1: 1 x 10^11 vg/gland (single gland), AAV2hAQP1: 3 x 10^10 vg/gland (both glands), AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- Where
- 6 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- MeiraGTx UK II Ltd
Herpes Zoster, Varicella Zoster
Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
The purpose of this clinical trial is to evaluate the safety, tolerability, and immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult subjects in the United States.
- Trial name
- NCT03820414
- Testing
- CRV 101
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Curevo Inc
Tumors
to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.
- Trial name
- NCT02271516
- Testing
- 188Re-BMEDA-liposome
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- National Atomic Research Institute, Taiwan
Cancer Patients With Solid Tumors
Dose-Escalation and Safety Trial of YN968D1
This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate…
- Trial name
- NCT01497704
- Testing
- YN968D1
- Where
- 2 sites in United States, South Korea
- Volunteers
- 55 people
- Sponsor
- Elevar Therapeutics
Malignant Solid Tumor
A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours
This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2).
- Trial name
- NCT03009214
- Testing
- AMC303
- Where
- 7 sites in Belgium, Spain
- Volunteers
- 55 people
- Sponsor
- amcure GmbH
Advanced Solid Tumors
A Phase I/II Clinical Study of WJ22096 Tablets in Patients With Advanced Tumors
This is a Phase I/II, open-label, preliminary study of safety, tolerability, pharmacokinetics, and efficacy. The study comprises three parts: a Dose Escalation cohort, a Dose Expansion cohort, and an Efficacy Expansion cohort.
- Trial name
- NCT07253116
- Testing
- WJ22096
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Jingao biomidical technology Co. Ltd.
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