Clinical trials: Dose Escalation and Safety
Amyotrophic Lateral Sclerosis (ALS)
A Study to Evaluate the Tolerability, Safety and Efficacy of VGN-R13 in Patients with ALS
The purpose of this trial is to evaluate safety and efficacy of intrathecal delivery of VGN-R13 as a treatment of Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- NCT06849609
- Testing
- VGN-R13
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Hong Chen
Type 2 Diabetes Mellitus
Japanese Phase 1 Multiple Ascending Dose Study
The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.
- Trial name
- NCT01515202
- Testing
- BMS-823778
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Neoplasms
Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior…
- Trial name
- NCT02964507
- Testing
- GSK525762, Fulvestrant
- Where
- 38 sites in United States, Australia and 5 more
- Volunteers
- 124 people
- Sponsor
- GlaxoSmithKline
Cancer, Prostate Cancer
ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 and pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer.
- Trial name
- NCT02325557
- Testing
- ADXS31-142, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- Advaxis, Inc.
Solid Tumor
Phase 1 Study of HLX10, a Monoclonal Antibody Targeting Programmed Death-1 (PD-1) in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of humanized anti-PD-1 monoclonal antibody, HLX10, in patients with advanced or metastatic tumors refractory to…
- Trial name
- NCT03468751
- Testing
- HLX10
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Henlix, Inc
Breast Cancer
A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers
This Phase I clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers.
- Trial name
- NCT07300202
- Testing
- Orialpha (BD-C) at 0.25 x anticipated therapeutic dose, Orialpha (BD-C) at 0.5 x anticipated therapeutic dose, Orialpha (BD-C) at the anticipated therapeutic dose
- Where
- Vietnam
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Oriplantee Company Limited
Leber Congenital Amaurosis, Inherited Retinal Diseases Caused by RPE65 Mutations
Safety and Efficacy Trial of HG004 for Leber Congenital Amaurosis Related to Rpe65 Gene Mutations (STAR)
The purpose of the study is to determine whether HG004 as gene therapy is safe and effective for the treatment of Leber Congenital Amaurosis caused by mutations in RPE65 gene.
- Trial name
- NCT05906953
- Testing
- HG004
- Where
- 3 sites in United States, China
- Volunteers
- 20 people
- Sponsor
- HuidaGene Therapeutics Co., Ltd.
Pulmonary Tuberculoses, High Risk Factors for Relapse
Safety and Immunogenicity Study of GX-70 in TB Patient
The purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis.
- Conditions
- Pulmonary Tuberculoses, High Risk Factors for Relapse, Treatment Failure
- Trial name
- NCT03159975
- Testing
- GX-70 by electroporation
- Sponsor
- Yonsei University
Malaria
Trial to Evaluate the Safety and Immunogenicity of a Placental Malaria Vaccine Candidate (PRIMVAC ) in Healthy Adults
The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered…
- Trial name
- PRIMALVAC (NCT02658253)
- Testing
- PRIMVAC, GLA-SE, Alhydrogel
- Where
- 2 sites in Burkina Faso, France
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Advanced or Metastatic Solid Tumors
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate (ADC) in participants with advanced or metastatic solid…
- Trial name
- NCT06752681
- Testing
- DAY301
- Where
- 11 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Advanced Solid Tumors
Safety Study of X-82 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent.
- Trial name
- NCT01296581
- Testing
- X-82
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Tyrogenex
Lupus
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are…
- Trial name
- NCT00299819
- Testing
- MEDI-545, MEDI 545
- Where
- 21 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- MedImmune LLC
Androgenetic Alopecia
the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending
The study is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose administration.
- Trial name
- NCT04502901
- Testing
- KX0826
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
Systemic Lupus Erythematosus
A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
A study of CM313 in subjects with systemic lupus erythematosus
- Trial name
- NCT05465707
- Testing
- CM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg
- Volunteers
- 40 people
- Sponsor
- Keymed Biosciences Co.Ltd
Ischemic Stroke
TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion
This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours.
- Trial name
- TEMPO-1 (NCT01654445)
- Testing
- Tenecteplase
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- University of Calgary
Cancer
Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid Tumors
The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR.
- Trial name
- NCT00485719
- Testing
- XL765 (SAR245409)
- Where
- 4 sites in United States, Spain
- Volunteers
- 83 people
- Sponsor
- Sanofi
Hypertension
Efficacy and Safety of Moxonidine in Indian Patients
The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.
- Trial name
- NCT00160277
- Testing
- Moxonidine
- Where
- 3 sites in India
- Volunteers
- 100 people
- Sponsor
- Solvay Pharmaceuticals
Head and Neck Neoplasms, Skin Neoplasms
Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer
This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, cutaneous or sub-cutaneous…
- Trial name
- NCT00993512
- Testing
- Amphinex (TPCS2a), Bleomycin, Illumination with CeramOptec laser
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- PCI Biotech AS
Healthy
Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food
The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg.
- Trial name
- NCT02256787
- Testing
- BILB 1941 ZW - single rising dose part, BILB 1941 ZW - solution, BILB 1941 ZW - tablet
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses
This is a randomised, single-blind, placebo-controlled Phase I study to investigate the safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to healthy male subjects.
- Trial name
- NCT01332214
- Testing
- AZD2820
- Where
- United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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