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MOD-4023 Study in Healthy Male Volunteers

2014-08-27 03:16:14 | BioPortfolio

Summary

This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection at escalating doses.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Healthy

Intervention

MOD-4023 (long lasting hGH), Placebo

Location

Tel Aviv Sourasky Medical Center
Tel Aviv
Israel
64239

Status

Completed

Source

Prolor Biotech, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:14-0400

Clinical Trials [1142 Associated Clinical Trials listed on BioPortfolio]

Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Protocol CP-4-004-EXT is designed as an open-label extension study assessing long-term MOD-4023 administration. It is open to subjects completing Phase 2 study in children with growth horm...

Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers. Following a 4-week screening ...

Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone...

A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency

This will be an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficien...

Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa

Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual functio...

PubMed Articles [12216 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics, Pharmacodynamics, and Safety of a Long-Acting Human Growth Hormone (MOD-4023) in Healthy Japanese and Caucasian Adults.

Daily injections of growth hormone (GH) as replacement therapy in GH-deficient (GHD) patients may cause poor compliance and inconvenience. C-terminal peptide-modified human GH (MOD-4023) has been deve...

Retrospective attention in short-term memory has a lasting effect on long-term memory across age.

Declines in both short- and long-term memory are typical of healthy aging. Recent findings suggest that retrodictive attentional cues ("retro-cues") that indicate the location of to-be-probed items in...

Is placebo response in antidepressant trials rising or not? A reanalysis of datasets to conclude this long-lasting controversy.

It had long been believed that placebo response rates in antidepressant trials have been increasing and that they were responsible for rising numbers of so-called failed antidepressant trials. Two rec...

Insulin degludec overdose may lead to long-lasting hypoglycaemia through its markedly prolonged half-life.

Overdose of insulin often causes long-lasting severe hypoglycaemia. Insulin degludec has the longest duration of action among the available insulin products; thus, an overdose of insulin degludec can ...

Long-lasting subjective effects of LSD in normal subjects.

Lysergic acid diethylamide (LSD) and other serotonergic hallucinogens can induce profound alterations of consciousness and mystical-type experiences, with reportedly long-lasting effects on subjective...

Medical and Biotech [MESH] Definitions

An N-substituted amphetamine analog. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems. It is commonly referred to as MDMA or ecstasy.

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Teleost hormones. A family of small peptides isolated from urophyses of bony fishes. They have many different physiological effects, including long-lasting hypotensive activity and have been proposed as antihypertensives. There are at least four different compounds: urotensin I, urotensin II, urotensin III, and urotensin IV.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

A major class of calcium-activated potassium channels that are found primarily in excitable CELLS. They play important roles in the transmission of ACTION POTENTIALS and generate a long-lasting hyperpolarization known as the slow afterhyperpolarization.

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