scholarly journals The anti-CD6 antibody itolizumab provides clinical benefit without lymphopenia in rheumatoid arthritis patients: results from a 6-month, open-label Phase I clinical trial

2017 ◽  
Vol 191 (2) ◽  
pp. 229-239 ◽  
Author(s):  
P. C. Rodríguez ◽  
D. M. Prada ◽  
E. Moreno ◽  
L. E. Aira ◽  
C. Molinero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Phase I ◽  
Clinical Benefit ◽  
Phase I Clinical Trial ◽  
Open Label ◽  
Open Label Phase

scholarly journals Open-label phase I clinical trial of Ad5-EBOV in Africans in China

2017 ◽  
Vol 13 (9) ◽  
pp. 2078-2085 ◽  
Author(s):  
Lihua Wu ◽  
Zhe Zhang ◽  
Hainv Gao ◽  
Yuhua Li ◽  
Lihua Hou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Open Label ◽  
Open Label Phase

scholarly journals Alpha-1 antitrypsin treatment of new-onset type 1 diabetes: An open-label, phase I clinical trial (RETAIN) to assess safety and pharmacokinetics

2018 ◽  
Vol 19 (5) ◽  
pp. 945-954 ◽  
Author(s):  
Gordon C Weir ◽  
Mario R Ehlers ◽  
Kristina M Harris ◽  
Sai Kanaparthi ◽  
Alice Long ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Open Label ◽  
Onset Type ◽  
Open Label Phase ◽  
Alpha 1 Antitrypsin ◽  
New Onset

scholarly journals Single‐dose pharmacokinetics of co‐crystal of tramadol–celecoxib: Results of a four‐way randomized open‐label phase I clinical trial in healthy subjects

2017 ◽  
Vol 83 (12) ◽  
pp. 2718-2728 ◽  
Author(s):  
Sebastián Videla ◽  
Mounia Lahjou ◽  
Anna Vaqué ◽  
Mariano Sust ◽  
Mercedes Encabo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Phase I ◽  
Healthy Subjects ◽  
Phase I Clinical Trial ◽  
Open Label ◽  
Open Label Phase

scholarly journals Pharmacokinetics of multiple doses of co-crystal of tramadol-celecoxib: findings from a four-way randomized open-label phase I clinical trial

2017 ◽  
Vol 84 (1) ◽  
pp. 64-78 ◽  
Author(s):  
Sebastián Videla ◽  
Mounia Lahjou ◽  
Anna Vaqué ◽  
Mariano Sust ◽  
Marisol Escriche ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Open Label ◽  
Multiple Doses ◽  
Open Label Phase

30. Open-label Phase I/II clinical trial of pyrimethamine for the treatment of chronic GM2 gangliosidosis

2010 ◽  
Vol 99 (2) ◽  
pp. S14 ◽  
Author(s):  
Joe Clarke ◽  
Edwin Kolodny ◽  
Don Mahuran ◽  
Maria Fuller ◽  
Michael Tropak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Gm2 Gangliosidosis ◽  
Open Label ◽  
Open Label Phase

scholarly journals A multicenter open-label phase I/II study to assess the safety, tolerability, and efficacy of three dose levels of TuNEX in patients with rheumatoid arthritis

2011 ◽  
Vol 74 (12) ◽  
pp. 544-551 ◽  
Author(s):  
Der-Yuan Chen ◽  
Ning-Sheng Lai ◽  
Ling-Ying Lu ◽  
Hsiu-Cheng Chou ◽  
Yi-Hsing Chen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Phase I ◽  
Open Label ◽  
Open Label Phase ◽  
Dose Levels

scholarly journals In vitro assessment and phase I randomized clinical trial of anfibatide a snake venom derived anti-thrombotic agent targeting human platelet GPIbα

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Benjamin Xiaoyi Li ◽  
Xiangrong Dai ◽  
Xiaohong Ruby Xu ◽  
Reheman Adili ◽  
Miguel Antonio Dias Neves ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Platelet Aggregation ◽  
Phase I ◽  
Human Platelet ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Phase ◽  
Deinagkistrodon Acutus

AbstractThe interaction of platelet GPIbα with von Willebrand factor (VWF) is essential to initiate platelet adhesion and thrombosis, particularly under high shear stress conditions. However, no drug targeting GPIbα has been developed for clinical practice. Here we characterized anfibatide, a GPIbα antagonist purified from snake (Deinagkistrodon acutus) venom, and evaluated its interaction with GPIbα by surface plasmon resonance and in silico modeling. We demonstrated that anfibatide interferds with both VWF and thrombin binding, inhibited ristocetin/botrocetin- and low-dose thrombin-induced human platelet aggregation, and decreased thrombus volume and stability in blood flowing over collagen. In a single-center, randomized, and open-label phase I clinical trial, anfibatide was administered intravenously to 94 healthy volunteers either as a single dose bolus, or a bolus followed by a constant rate infusion of anfibatide for 24 h. Anfibatide inhibited VWF-mediated platelet aggregation without significantly altering bleeding time or coagulation. The inhibitory effects disappeared within 8 h after drug withdrawal. No thrombocytopenia or anti-anfibatide antibodies were detected, and no serious adverse events or allergic reactions were observed during the studies. Therefore, anfibatide was well-tolerated among healthy subjects. Interestingly, anfibatide exhibited pharmacologic effects in vivo at concentrations thousand-fold lower than in vitro, a phenomenon which deserves further investigation.Trial registration: Clinicaltrials.gov NCT01588132.

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