Confirmation of the Cardiac Safety of PGF2α Receptor Antagonist OBE022 in a First‐in‐Human Study in Healthy Subjects, Using Intensive ECG Assessments
Sign Up to like & getrecommendations! Published in 2018 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.447
Abstract: OBE022, a new orally active prostaglandin F2α receptor antagonist (OBE022) with myometrial selectivity is being developed to reduce uterine contractions during preterm labor. This first‐in‐human study evaluated the effect of OBE022 following multiple doses on… read more here.
Keywords: receptor antagonist; study; effect; human study ... See more keywords
A Randomized First‐in‐Human Study With UB‐312, a UBITh® α‐Synuclein Peptide Vaccine
Sign Up to like & getrecommendations! Published in 2022 at "Movement Disorders"
DOI: 10.1002/mds.29016
Abstract: α‐Synuclein (αSyn) is believed to play a central role in Parkinson's disease (PD) neuropathology and is considered a target for disease modification. UB‐312 is a synthetic αSyn peptide conjugated to a T helper peptide and… read more here.
Keywords: randomized first; study 312; peptide; 312 ubith ... See more keywords
Pharmacokinetics of LBPT and its primary metabolites, as well as tolerability in the first‐in‐human study
Sign Up to like & getrecommendations! Published in 2017 at "European Journal of Pharmaceutical Sciences"
DOI: 10.1016/j.ejps.2016.12.038
Abstract: Background: LBPT is a novel platelet‐activating factor (PAF) receptor antagonist that is developed for the treatment of rheumatoid arthritis. The purpose of this first‐in‐human study was to evaluate the tolerability and safety of LBPT, to… read more here.
Keywords: primary metabolites; pharmacokinetics lbpt; study; human study ... See more keywords
First-in-human study to assess the pharmacokinetics, tolerability, and safety of single-dose oxybutynin hydrochloride administered via a microprocessor-controlled intravaginal ring
Sign Up to like & getrecommendations! Published in 2023 at "Drug Delivery"
DOI: 10.1080/10717544.2023.2180113
Abstract: Abstract Polymeric drug-releasing vaginal rings are useful for both local and systemic administration of drugs via the intravaginal route. Typically, they provide continuous sustained or controlled release of drug(s) over extended time periods, thereby avoiding… read more here.
Keywords: oxybutynin; oxybutynin hydrochloride; human study; dose oxybutynin ... See more keywords
Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis
Sign Up to like & getrecommendations! Published in 2023 at "mAbs"
DOI: 10.1080/19420862.2023.2209920
Abstract: ABSTRACT Psoriasis, an immune-mediated inflammatory disease, affects nearly 125 million people globally. The interleukin (IL)-17A homodimer is a key driver of psoriasis and other autoimmune diseases, including psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis.… read more here.
Keywords: molecule; affibody; human study; psoriasis ... See more keywords
A novel bionic constructional left atrial appendage occlude device: the result of preclinical experiment and first-in-human study
Sign Up to like & getrecommendations! Published in 2024 at "European Heart Journal"
DOI: 10.1093/eurheartj/ehae666.2487
Abstract: Left atrial appendage occlusion (LAAO) has emerged as a viable substitute for oral anticoagulation (OAC) for stroke prevention among individuals with atrial fibrillation (AF) these years. The high variability of left atrial appendage (LAA) in… read more here.
Keywords: human study; left atrial; device; first human ... See more keywords
First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug
Sign Up to like & getrecommendations! Published in 2024 at "Journal of Antimicrobial Chemotherapy"
DOI: 10.1093/jac/dkae107
Abstract: Abstract Background The clinical candidate alpibectir augments the activity of, and overcomes resistance to, the anti-TB drug ethionamide in vitro and in vivo. Objectives A Phase 1, double-blind, randomized, placebo-controlled study to investigate the safety,… read more here.
Keywords: human study; anti drug; drug; first human ... See more keywords
First‐in‐human study of eliapixant (BAY 1817080), a highly selective P2X3 receptor antagonist: Tolerability, safety and pharmacokinetics
Sign Up to like & getrecommendations! Published in 2022 at "British Journal of Clinical Pharmacology"
DOI: 10.1111/bcp.15358
Abstract: Neuronal hypersensitisation due to adenosine triphosphate‐dependent P2X3 receptor signalling plays a significant role in several disorders including chronic cough and endometriosis. This first‐in‐human study of eliapixant (BAY 1817080) investigated the tolerability, safety and pharmacokinetics (PK)… read more here.
Keywords: eliapixant bay; bay 1817080; p2x3 receptor; study eliapixant ... See more keywords
First‐in‐human study of ONO‐4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors
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DOI: 10.1111/cas.15574
Abstract: EP4, a prostaglandin E2 receptor, has shown an immunosuppressive activity on cancer cells. This first‐in‐human study evaluated ONO‐4578, a highly selective EP4 antagonist, as monotherapy and in combination with nivolumab in patients with advanced or… read more here.
Keywords: combination; ono 4578; solid tumors; human study ... See more keywords
First‐in‐human study demonstrating the safety and clinical efficacy of novel anti‐IL‐17A monoclonal antibody CJM112 in moderate to severe plaque psoriasis
Sign Up to like & getrecommendations! Published in 2020 at "Journal of the European Academy of Dermatology and Venereology"
DOI: 10.1111/jdv.17071
Abstract: Anti‐IL‐17A IgG/κ monoclonal antibody CJM112 binds both IL‐17A and IL‐17AF. The purpose of this First‐in‐Human study was to assess CJM112 effects on safety and efficacy in patients with moderate to severe plaque psoriasis. read more here.
Keywords: antibody cjm112; anti 17a; human study; first human ... See more keywords
First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low-dose Cyclophosphamide in Patients with Advanced Malignancies
Sign Up to like & getrecommendations! Published in 2019 at "Clinical Cancer Research"
DOI: 10.1158/1078-0432.ccr-19-2609
Abstract: Purpose: This first-in-human study assessed the safety, tolerability, dose-limiting toxicities (DLT), antitumor activity, and pharmacokinetics of cemiplimab, a monoclonal anti-programmed cell death-1 (PD-1), as monotherapy and in combination with hypofractionated radiotherapy (hfRT) and/or cyclophosphamide (CPA)… read more here.
Keywords: patients advanced; human study; first human; combination ... See more keywords