Track topics on Twitter Track topics that are important to you
This study will be a Phase I, FiH, randomized, single-blind, placebo-controlled, SAD study in male patients with T2DM, performed at a single study center. The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65 years will be included.
Part A will assess the safety and tolerability of SAD of ID injection of AZD8601 (modified VEGF-A RNA) and Part B will evaluate the pharmacodynamic effects of ID injection of AZD8601 in forearm skin. AZD8601 is a VEGF-A modRNA under development as a novel modality for local production of human VEGF-A protein and is developed for the treatment of diabetic patients with ulcers. Each patient in Part A will be involved in the study for 7 to 8 weeks. Each patient in Part B will be involved in the study for 5 to 6 weeks.
Safety and tolerability variables includes Adverse events (AEs), Vital signs (BP, pulse), ECG, Hematology, Clinical chemistry, Urinalysis.
The study will include patients with T2DM that are on stable doses of 1 to 2 anti-diabetic medications. The T2DM patients may also be on medications for comorbidities such as hypertension, dyslipidemia, hyperuricemia, thyroid disorders, benign prostate hyperplasia etc. (e.g. diuretics, statins, allopurionol, thyroxin), but must be healthy otherwise.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Male Subjects With Type II Diabetes (T2DM)
AZD8601+Placebo (SAD), AZD8601+Placebo, Placebo+Placebo
Not yet recruiting
Published on BioPortfolio: 2016-10-18T02:08:21-0400
This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose- escalation study in otherwise healthy cat-, dust mite-, or Bermuda grass-allergic male and female ...
In the proposed study, investigators aim to investigate the role of interpersonal trust in the conditioned placebo analgesia process with healthy male subjects in a standardized experiment...
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in m...
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunte...
This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705 from a n...
Sequential parallel comparison design (SPCD) was proposed to reduce placebo response in a randomized trial with placebo comparator. Subjects are randomized between placebo and drug in stage 1 of the t...
Research shows that placebo analgesia and nocebo hyperalgesia can be induced through observational learning. Our aim was to replicate and extend these results by studying the influence of the type and...
Soybean is recognized as a beneficial food with various functional components, such as β-conglycinin, which improves lipid metabolism. We evaluated the effects of the β-conglycinin-rich soybean Nana...
Research on placebo/nocebo effects suggests that expectations can influence treatment outcomes, but placebo/nocebo effects are not always evident. This research demonstrates that a provider's social b...
The current study evaluated the effects of licorice flavonoid oil (LFO) on increasing the muscle mass of elderly populations using a randomized, double-blind, placebo-controlled study. Fifty participa...
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.
MYCOBACTERIUM infections of the male reproductive tract (GENITALIA, MALE).
Pathological processes involving the male reproductive tract (GENITALIA, MALE).
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...