Results 181 to 190 of about 17,568,133 (310)

Effect of vosoritide on genu varum in children with achondroplasia after 1 year in randomized placebo-controlled trials. [PDF]

J Endocr Soc
White KK, Irving M, Mukherjee S, Rivat C, Sabir I, Dee A, Savarirayan R.   +6 more
europepmc   +1 more source

Revisiting the Ethics of Urate‐Lowering Therapy Clinical Trials for Gout Management

Arthritis &Rheumatology, EarlyView.
Lisa K. Stamp, Dien Ho, Nicola Dalbeth
wiley   +1 more source

Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis

British Journal of Clinical Pharmacology, EarlyView.
Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
wiley   +1 more source

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

British Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort, Marella C. E. van Ruissen, Lisanne C. A. Smidt, Naomi B. Klarenbeek, Philip H. K. Kremer, Manon A. A. Jansen, Jacobus Burggraaf, Joop M. A. van Gerven, Matthijs Moerland   +8 more
wiley   +1 more source

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase 1 Study of Firsekibart in Chinese Healthy Participants. [PDF]

Clin Pharmacol Drug Dev
Yong X, Du X, Li X, Chen Y, Zhu X, Luo T, Xu Q.   +6 more
europepmc   +1 more source

Safety, tolerability and pharmacokinetics of DNDI‐6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim The benzoxaborole derivative DNDI‐6148 is an antiparasitic agent with activity against multiple Leishmania protozoan species, including L. infantum and L. donovani, which cause visceral leishmaniasis. We investigated the safety, tolerability and pharmacokinetics of single oral doses of DNDI‐6148 in a randomized, parallel‐group, placebo‐controlled ...
Jean‐Yves Gillon, Sophie Delhomme, Delphine Launay, Séverine Blesson, Stéphanie Braillard, Pegah Maghdooni, Frauke Assmus, Richard Hoglund, Joel Tarning, Sabrina Loyau, Byron Arana, Mathilde Latreille‐Barbier, Yves Donazzolo   +12 more
wiley   +1 more source

Hydroxychloroquine sulfate tablets for patients with recurrent implantation failure: a double-blind, randomized, placebo-controlled trial. [PDF]

Trials
Han DL, Li L, Shi J, Ge YM, Yang SL, Chu YF, Mai ZY, Zhang YW, Chen H, Yue J, He GM, Xiang HF, Zhao J, Li R.   +13 more
europepmc   +1 more source

Population pharmacokinetics of TBAJ‐587 and its main metabolites—Evaluation of different loading dose strategies and early dose selection

British Journal of Clinical Pharmacology, EarlyView.
Background and Aim The rise of drug‐resistant tuberculosis (TB) poses a need for new drugs and combinations. TBAJ‐587, a new diarylquinoline (DARQ), has shown promising efficacy in preclinical studies. This work aimed to describe the pharmacokinetics (PK) of TBAJ‐587 and its metabolites M2 and M3 after single ascending dosing in healthy volunteers and ...
Albin A. M. Leding, Paul Bruinenberg, Almari Conradie, Jerry Nedelman, Antonio Lombardi, Dean Hickman, Ulrika S. H. Simonsson   +6 more
wiley   +1 more source

Tirzepatide in Adults With Type 1 Diabetes: A Phase 2 Randomized Placebo-Controlled Clinical Trial. [PDF]

Diabetes Care
Snaith JR, Frampton R, Samocha-Bonet D, Greenfield JR.   +3 more
europepmc   +1 more source

A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis.

New England Journal of Medicine, 2016
F. Nevens, P. Andreone, G. Mazzella, S. Strasser, C. Bowlus, P. Invernizzi, J. Drenth, P. Pockros, J. Reguła, U. Beuers, M. Trauner, Dave E. Jones, A. Floreani, S. Hohenester, V. Luketic, M. Shiffman, K. V. van Erpecum, V. Vargas, C. Vincent, G. Hirschfield, Hemant A Shah, B. Hansen, K. Lindor, H. Marschall, K. Kowdley, R. Hooshmand-Rad, T. Marmon, S. Sheeron, R. Pencek, L. Macconell, M. Pruzanski, D. Shapiro   +31 more
semanticscholar   +1 more source