Clinical trials: Dose Escalation and Safety
Dengue
Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.
- Trial name
- NCT01477580
- Testing
- Low-dose V180 with low-dose ISCOMATRIX™ adjuvant, Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant, Medium-dose V180 (non-adjuvanted)
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Neoplasm
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
Primary Objectives: Part 1 To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors.
- Trial name
- NCT04418661
- Testing
- Vociprotafib, Pembrolizumab, Adagrasib
- Where
- 20 sites in United States, Argentina and 5 more
- Volunteers
- 65 people
- Sponsor
- Sanofi
Neoplasms
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
- Trial name
- NCT02222922
- Testing
- PF-06647020 Q3W, fluconazole, PF-06647020 Q2W
- Where
- 17 sites in United States, Spain
- Volunteers
- 138 people
- Sponsor
- Pfizer
Fever, Sweats, and Hot Flashes, Infection
Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia
RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing infection in young patients with fever and neutropenia receiving chemotherapy for blood disease or cancer.
- Conditions
- Fever, Sweats, and Hot Flashes, Infection, Leukemia, Lymphoma
- Trial name
- NCT00886496
- Testing
- recombinant human mannose-binding lectin
- Where
- 3 sites in United States
- Sponsor
- Enzon Pharmaceuticals, Inc.
Acute Postoperative Pain
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 in Healthy Volunteers
This study is the first time into human study (FTIH) for HYR-PB21 for injection. The study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending and single subcutaneous dose of HYR-PB21 for…
- Trial name
- NCT04169256
- Testing
- HYR-PB21, Liposomal bupivacaine, Normal Saline
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fruithy Medical Pty Ltd
Cancer, Non Small Cell Lung Cancer
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel
The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.
- Conditions
- Cancer, Non Small Cell Lung Cancer, Epithelial Ovarian Cancer
- Trial name
- NCT01000896
- Testing
- AZD0530, Carboplatin, paclitaxel
- Where
- 2 sites in Japan
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Geographic Atrophy Secondary to Age-related Macular Degeneration
A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary…
- Trial name
- VISION (NCT06765980)
- Testing
- VV-14295
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 62 people
- Sponsor
- Kriya Therapeutics, Inc.
Infections, Meningococcal
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).
- Trial name
- NCT02639351
- Testing
- Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R, Investigational MenC-CRM adjuavnted with 25 ug of LHD153R, Investigational MenC-CRM adjuavnted with 50 ug of LHD153R
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy, Active Non-segmental Vitiligo
Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body in Healthy Volunteers After Single-dose Administration, and in Non-segmental Vitiligo Patients and Alopecia Areata Patients After Multiple-dose Administration
A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and…
- Conditions
- Healthy, Active Non-segmental Vitiligo, Severe Alopecia Areata
- Trial name
- NCT07554222
- Testing
- Baricitinib tablets, IBI3013
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy
MOD-4023 Study in Healthy Male Volunteers
This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection at escalating doses.
- Trial name
- NCT01060722
- Testing
- MOD-4023 (long lasting hGH)
- Where
- Israel
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Healthy Adult Subjects, Healthy Elderly Subjects
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118
- Trial name
- NCT02691702
- Testing
- BIIB118, Melatonin
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Biogen
Metastatic Castration Resistant Prostate Cancer
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).
- Trial name
- NCT05124795
- Testing
- IMU-935
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Immunic AG
Healthy Volunteers, Generalized Anxiety Disorder (GAD)
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder…
- Conditions
- Healthy Volunteers, Generalized Anxiety Disorder (GAD), Bipolar Disorder (BPD)
- Trial name
- MAD (NCT06024239)
- Testing
- ABBV-932
- Where
- 3 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AbbVie
Advanced Solid Tumors
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors
This study is designed to characterize the absorption, distribution, metabolism and excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C…
- Trial name
- NCT01299701
- Testing
- ASA404
- Where
- New Zealand
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Covid19
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
- Trial name
- NCT04532294
- Testing
- BGB DXP593
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene
Melanoma, Prostate Adenocarcinoma
Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors
The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as an infusion to treat patients who bear advanced solid tumors that are dependent on arginine (melanoma, renal cell carcinoma, prostate…
- Trial name
- NCT02285101
- Testing
- PEG-BCT-100
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Bio-Cancer Treatment International Limited
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple repeat oral doses of PF-06372865 in healthy adult subjects.
- Trial name
- NCT03351751
- Testing
- PF-06372865
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subject
A Study of ALS-4 in Healthy Adults Subjects
A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.
- Trial name
- NCT05274802
- Testing
- ALS-4
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aptorum International Limited
Influenza Immunization
Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above
This is a Phase 1, parallel, randomized, active-controlled, multi-center, dose-esclation study with a Master Protocol design which will include several substudies that are developed to evaluate the safety and immunogenicity of…
- Trial name
- NCT05829356
- Testing
- H3 mRNA / LNP Vaccine, Quadrivalent recombinant influenza Vaccine (RIV4)
- Where
- 8 sites in Australia, United Kingdom
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Non-Small Cell Lung Cancer, Carcinoma
MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC
This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated.
- Trial name
- NCT02592577
- Testing
- Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 28 people
- Sponsor
- Adaptimmune
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