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GSK1070806 Safety and Tolerability in Healthy Volunteers
Study Summary
This trial will test the safety, tolerability, and effect of a drug on healthy people of various ancestries.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- You or your family have a history of heart muscle problems.You have a history of severe allergic reactions to multiple drugs or strong reactions to topical corticosteroids.Your ALT levels are higher than 1.5 times the normal range.You have a history of ongoing liver problems, except for some specific conditions like Gilbert's syndrome or gallstones that don't cause symptoms.You have any medical conditions that can affect how the study drug works in your body or might make it risky for you to take the study drug.You have had lymphoma, leukemia, or any other type of cancer except for a specific type of skin cancer that was removed and has not spread for at least 5 years.You have a weakened immune system.You had COVID-19 or were in close contact with someone who had it within the last two weeks.You have had Stevens Johnson Syndrome in the past.Chinese participants who were born in mainland China, Hong Kong, Macau or Taiwan, have four ethnic Chinese grandparents and two ethnic Chinese parents, and have lived outside these areas for less than 10 years.You have a history of bleeding problems.Your total bilirubin levels are higher than 1.5 times the upper limit of normal, unless only the direct bilirubin is high and the total bilirubin is not too high.You have a history of tuberculosis or a positive QuantiFERON test for tuberculosis.You had a severe viral infection within the last 6 weeks, or you have had repeated outbreaks of herpes in the past 2 years.Your heart's electrical activity (QT interval) is longer than 450 milliseconds.You are a healthy man or woman with Japanese ancestry, born in Japan, and have lived outside of Japan for less than 10 years.You weigh between 45 and 100 kilograms and your body mass index (BMI) is between 18 and 32 kilograms per square meter.You are eligible if you identify as Caucasian/European and have a family background of Caucasian/European ancestry.You are between 18 and 65 years old when you agree to join the study.
- Group 1: Part A: Placebo
- Group 2: Part A: GSK1070806
- Group 3: Part B: GSK1070806
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does Part A: GSK1070806 pose any adverse risks to participants?
"Due to its limited track record, GSK1070806 is classified as a Phase 1 trial. As such, the safety rating of this medication was assessed at 1 by our team at Power."
What is the scope of participation in this clinical experiment?
"Accurate. According to clinicaltrials.gov, this medical study is actively searching for 38 subjects from two separate sites. It was initially published on November 4th 2022 and then updated on January 20th 2023."
Are they currently enrolling participants in this experiment?
"The trial, which was initially published on November 4th 2022 and last modified on January 20th 2023, is currently recruiting participants, as reported by clinicaltrials.gov."
Are geriatric patients able to participate in this experiment?
"This clinical trial requires eligible candidates to be between 18 and 65 years old. For those not meeting this criteria, 97 trials are available for under-18s, while 151 studies exist for over-65s."
Might I be permitted to take part in this investigation?
"This medical research is looking for 38 atopic dermatitis sufferers aged between 18 and 65. To be eligible, subjects must satisfy the following requirements: body mass index in a range of 18-32 kilograms/metre squared, female participants that are either non-childbearing potential (WONCBP) or using highly reliable contraception methods with low user dependency rate, capability to give informed consent, healthy Japanese natives with four ethnic Japanese grandparents and two parents as well as Chinese residents born in mainland China, Hong Kong Macau or Taiwan who have resided outside these locations no more than 10 years prior to screening phase beginning. Furthermore all candidates need"
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