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Safety and Tolerability of Anti–microRNA-328 Ophthalmic Solution, SHJ002, in Pediatric Subjects: First-in-Human Clinical Study

Clinical therapeutics, 2024-09

2024

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THE AMETHYST (ADVANCED MESENCHYMAL ENHANCED CELL THERAPY FOR SEPTIC) TRIAL: A FIRST-IN-HUMAN, DOSE-ESCALATION PHASE 1 SAFETY TRIAL OF GENETICALLY ENHANCED MSCS (GEM00220) APPEARED SAFE AND WELL TOLERATED IN PATIENTS WITH SEPTIC SHOCK

Cytotherapy (Oxford, England), 2024-06, Vol.26 (6), p.e5-e5

2024

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3D Printing Pharmaceuticals: Drug Development to Frontline Care

Trends in pharmacological sciences (Regular ed.), 2018-05, Vol.39 (5), p.440-451

2018

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Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity Against SARS-CoV-2

Antimicrobial agents and chemotherapy, 2021-05, Vol.65 (5)

2021

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A Randomized First‐in‐Human Study With UB‐312, a UBITh® α‐Synuclein Peptide Vaccine

Movement disorders, 2022-07, Vol.37 (7), p.1416-1424

2022

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First-in-human, Randomized, Double-blind Clinical Trial of Differentially Adjuvanted PAMVAC, A Vaccine Candidate to Prevent Pregnancy-associated Malaria

Clinical infectious diseases, 2019-10, Vol.69 (9), p.1509-1516

2019

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Enhancing the pharmacokinetic properties of recombinant factor VIII: first‐in‐human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A

Journal of thrombosis and haemostasis, 2013-04, Vol.11 (4), p.670-678

2013

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Preclinical and translational pharmacology of afucosylated anti‐CCR8 antibody for depletion of tumour‐infiltrating regulatory T cells

British journal of pharmacology, 2024-07, Vol.181 (13), p.2033-2052

2024

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First‐in‐human study with ACT‐539313, a novel selective orexin‐1 receptor antagonist

British journal of clinical pharmacology, 2020-07, Vol.86 (7), p.1377-1386

2020

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First‐in‐human study of E7130 (a tumor microenvironment‐ameliorating microtubule inhibitor) in patients with advanced solid tumors: Primary results of the dose‐escalation part

Cancer, 2023-08, Vol.129 (15), p.2348-2359

2023

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A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants

Antimicrobial agents and chemotherapy, 2020-10, Vol.64 (11)

2020

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Healthy volunteers in first‐in‐human oncology drug development for small molecules

British journal of clinical pharmacology, 2022-02, Vol.88 (4), p.1773-1784

2022

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Results From the First‐in‐Human Study With Ozanimod, a Novel, Selective Sphingosine‐1‐Phosphate Receptor Modulator

Journal of clinical pharmacology, 2017-08, Vol.57 (8), p.988-996

2017

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A first‐in‐human study of the novel immunology antibody–drug conjugate, ABBV‐3373, in healthy participants

British journal of clinical pharmacology, 2024-01, Vol.90 (1), p.189-199

2024

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Safety, Tolerability, and Pharmacokinetic Characteristics of a Novel Nonopioid Analgesic, VVZ‐149 Injections in Healthy Volunteers: A First‐in‐Class, First‐in‐Human Study

Journal of clinical pharmacology, 2018-01, Vol.58 (1), p.64-73

2018

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Pharmacokinetics, pharmacodynamics and safety of the novel C‐X‐C chemokine receptor 3 antagonist ACT‐777991: Results from the first‐in‐human study in healthy adults

British journal of clinical pharmacology, 2024-02, Vol.90 (2), p.588-599

2024

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Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness

British journal of clinical pharmacology, 2023-01, Vol.89 (1), p.340-350

2023

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Safety, Tolerability, and Pharmacokinetics of the Novel Antiviral Agent Ensitrelvir Fumaric Acid, a SARS-CoV-2 3CL Protease Inhibitor, in Healthy Adults

Antimicrobial agents and chemotherapy, 2022-10, Vol.66 (10), p.e0063222-e0063222

2022

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Safety, tolerability and pharmacokinetic characterisation of DACRA KBP‐042 in healthy male subjects

British journal of clinical pharmacology, 2021-12, Vol.87 (12), p.4786-4796

2021

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Arginase-1 targeting peptide vaccine in patients with metastatic solid tumors – A phase I trial

Frontiers in immunology, 2022-10, Vol.13, p.1023023-1023023

2022

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Ultralow temperature cryoablation using near‐critical nitrogen for cavotricuspid isthmus‐ablation, first‐in‐human results

Journal of cardiovascular electrophysiology, 2021-08, Vol.32 (8), p.2025-2032

2021

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One‐year initial efficacy and safety outcomes of the premounted dry‐pericardium Vienna self‐expandable transcatheter aortic valve system: A first‐in‐human VIVA feasibility study

Catheterization and cardiovascular interventions, 2024-06, Vol.103 (7), p.1111-1124

2024

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Pharmacokinetic and pharmacodynamic profiling of a P2X7 receptor allosteric modulator GSK1482160 in healthy human subjects

British journal of clinical pharmacology, 2013-01, Vol.75 (1), p.197-207

2013

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IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage

Annals of surgery, 2022-01, Vol.275 (1), p.73-79

2022

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Transcatheter mitral valve replacement with Mi‐thos system: First‐in‐human experience

Catheterization and cardiovascular interventions, 2024-01, Vol.103 (1), p.153-159

2024

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Safety and Tolerability of Anti–microRNA-328 Ophthalmic Solution, SHJ002, in Pediatric Subjects: First-in-Human Clinical Study

THE AMETHYST (ADVANCED MESENCHYMAL ENHANCED CELL THERAPY FOR SEPTIC) TRIAL: A FIRST-IN-HUMAN, DOSE-ESCALATION PHASE 1 SAFETY TRIAL OF GENETICALLY ENHANCED MSCS (GEM00220) APPEARED SAFE AND WELL TOLERATED IN PATIENTS WITH SEPTIC SHOCK

3D Printing Pharmaceuticals: Drug Development to Frontline Care

Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity Against SARS-CoV-2

A Randomized First‐in‐Human Study With UB‐312, a UBITh® α‐Synuclein Peptide Vaccine

First-in-human, Randomized, Double-blind Clinical Trial of Differentially Adjuvanted PAMVAC, A Vaccine Candidate to Prevent Pregnancy-associated Malaria

Enhancing the pharmacokinetic properties of recombinant factor VIII: first‐in‐human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A

Preclinical and translational pharmacology of afucosylated anti‐CCR8 antibody for depletion of tumour‐infiltrating regulatory T cells

First‐in‐human study with ACT‐539313, a novel selective orexin‐1 receptor antagonist

First‐in‐human study of E7130 (a tumor microenvironment‐ameliorating microtubule inhibitor) in patients with advanced solid tumors: Primary results of the dose‐escalation part

A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants

Healthy volunteers in first‐in‐human oncology drug development for small molecules

Results From the First‐in‐Human Study With Ozanimod, a Novel, Selective Sphingosine‐1‐Phosphate Receptor Modulator

A first‐in‐human study of the novel immunology antibody–drug conjugate, ABBV‐3373, in healthy participants

Safety, Tolerability, and Pharmacokinetic Characteristics of a Novel Nonopioid Analgesic, VVZ‐149 Injections in Healthy Volunteers: A First‐in‐Class, First‐in‐Human Study

Pharmacokinetics, pharmacodynamics and safety of the novel C‐X‐C chemokine receptor 3 antagonist ACT‐777991: Results from the first‐in‐human study in healthy adults

Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness

Safety, Tolerability, and Pharmacokinetics of the Novel Antiviral Agent Ensitrelvir Fumaric Acid, a SARS-CoV-2 3CL Protease Inhibitor, in Healthy Adults

Safety, tolerability and pharmacokinetic characterisation of DACRA KBP‐042 in healthy male subjects

Arginase-1 targeting peptide vaccine in patients with metastatic solid tumors – A phase I trial

Ultralow temperature cryoablation using near‐critical nitrogen for cavotricuspid isthmus‐ablation, first‐in‐human results

One‐year initial efficacy and safety outcomes of the premounted dry‐pericardium Vienna self‐expandable transcatheter aortic valve system: A first‐in‐human VIVA feasibility study

Pharmacokinetic and pharmacodynamic profiling of a P2X7 receptor allosteric modulator GSK1482160 in healthy human subjects

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage

Transcatheter mitral valve replacement with Mi‐thos system: First‐in‐human experience

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