A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070… (NCT05590338) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive
United States38 participantsStarted 2022-11-04
Plain-language summary
This study is divided into two parts:
Part A of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamic (PD) effect of a single intravenous (IV) infusion dose of GSK1070806 when administered to healthy participants of Japanese, Chinese and European/Caucasian ancestry.
Part B of the study is an open label single cohort arm to assess the safety, tolerability, PK and PD effect of a single IV bolus low dose of GSK1070806 in healthy participants of European/Caucasian ancestry.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring \[12-lead Electrocardiogram (ECGs)\]
* Between 18 and 65 years of age inclusive, at the time of signing the informed consent
* Body weight within the range 45 - 100 kilograms (kg) and body mass index (BMI) within the range 18-32 kilogram/meter square (kg/m\^2) (inclusive)
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a woman of non-childbearing potential (WONCBP) OR
* Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective \[with a failure rate of less than 1 percent (\<1%) per year\], with low user dependency
* Capable of giving signed informed consent
* Participants of Japanese ancestry are eligible based on meeting all of the following:
* Healthy male and female participants born in Japan
* Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents
* Have lived outside Japan for less than 10 years at the time of screening
* Chinese participants are eligible based on meeting all of the following:
* Healthy male and female participants born in mainland China, Hong Kong, Macau or Taiwan
* Descendants of four ethnic Chinese grandparents and two ethnic Chinese parents
* Have lived outside mainland China, Hong Kong, Macau or Taiwan for …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Serum GSK1070806 area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-∞])
Timeframe: Up to Week 24
2
Part A: Serum GSK1070806 area under the concentration-time curve from time zero to the last quantifiable time (AUC(0-t))
Timeframe: Up to Week 24
3
Part A: Maximum observed serum concentration (Cmax) of GSK1070806
Timeframe: Up to Week 24
4
Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)