scholarly journals TROIKA‐1: A double‐blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU‐Herceptin ® and US‐Herceptin ® in healthy male subjects

2021 ◽  
Vol 9 (4) ◽  
Author(s):  
Martin Demarchi ◽  
Pierre Coliat ◽  
Kristi Mclendon ◽  
Jocelyn Chung Shii Hii ◽  
Peggy Feyaerts ◽  
...  
Keyword(s):  
Pharmacokinetic Profile ◽  
Healthy Male ◽  
Double Blind ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Male Subjects

A double-blind, placebo-controlled, parallel group study of oral trovafloxacin on bowel microflora in healthy male volunteers

1998 ◽  
Vol 176 (6) ◽  
pp. 27S-31S ◽  
Author(s):  
Claartje H.M van Nispen ◽  
Andy I.M Hoepelman ◽  
Marja Rozenberg-Arska ◽  
Jan Verhoef ◽  
Lynn Purkins ◽  
...  
Keyword(s):  
Healthy Male ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Male Volunteers ◽  
Male Volunteers ◽  
Parallel Group Study ◽  
Parallel Group

scholarly journals Safety, tolerability and pharmacokinetic characterisation of DACRA KBP-042 in healthy male subjects

2021 ◽  
Author(s):  
Kim Henriksen ◽  
Karen Broekhuizen ◽  
Wadim de Boon ◽  
Morten Karsdal ◽  
Asger Bihlet ◽  
...  
Keyword(s):  
Human Study ◽  
Pharmacokinetic Profile ◽  
Healthy Male ◽  
Double Blind ◽  
Linear Pharmacokinetic ◽  
Dose Study ◽  
Dose Levels ◽  
Dose Dependent ◽  
Male Subjects ◽  
Single Ascending Dose Study

There is a need for anti-diabetic agents successfully targeting insulin sensitivity and treating obesity control at the same time. The aim of this first-in-human study was 1) to evaluate safety and tolerability; 2) to evaluate pharmacokinetics and 3) to assess indications of receptor engagement of single ascending doses of KBP-042, a Dual Amylin and Calcitonin Receptor Agonists (DACRA) that has shown promising preclinical data, with superior activity in terms of typical amylin-induced responses including reduction of food intake, weight loss and gluco-regulatory capacities. A randomised double-blind placebo-controlled single ascending dose study was performed with six dose levels of KBP-042 (5, 7.5, 10, 20, 20 evening and 40µg) in healthy male adults. KBP-042 or placebo was administered as a single dose after an overnight fast, followed by a standardized lunch after four hours. KBP-042 was associated with dose-dependent complaints of nausea and vomiting, with a lack of tolerability at doses of 20µg and above. Doses of 5 to 40 μg KBP-042 were behaved according to a linear pharmacokinetic profile. Indications of target receptor engagement were observed at the level of glucose control and lowering of bone resorption, compared to placebo. The results of this study showed that doses up to 40 μg were safe, although tolerability was not present at the highest doses. The study confirmed target receptor engagement at the studied doses.

884: Phase I, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Investigate the Safety, Tolerability, and Pharmacokinetics of DA-8159

2004 ◽  
Vol 171 (4S) ◽  
pp. 234-234 ◽  
Author(s):  
Harin Padma-Nathan ◽  
Jae Seung Pacik ◽  
Byoung Ok Ahn ◽  
Kyung Koo Kang ◽  
Mi Young Bahng ◽  
...  
Keyword(s):  
Phase I ◽  
Controlled Study ◽  
Healthy Male ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Male Subjects
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