CompletedPhase IInterventional

A 2-part study to investigate the safety, tolerability and effect of MB272 in healthy volunteers

This study, known as MB272, was an early-stage trial investigating a potential new medicine called GS-0272 in healthy adults aged 18 to 65. The main goals were to see if the drug was safe, discover how well people tolerated it, and understand how it behaved in the body. Researchers gave single doses of the drug in different strengths, either directly into a vein (infusion) or under the skin (injection). They also compared it to a dummy treatment (placebo). Information from this study could help with developing treatments for autoimmune diseases in the future, although participants didn't receive any direct health benefits themselves.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Gilead Sciences (United States)

Enrolment target

Start

07 Jul 2022

Estimated completion

05 Mar 2024

Healthy volunteers

What is this study about?

This study, known as MB272, was a very early-stage trial (called a Phase I study) looking into a new investigational drug named GS-0272. The main purpose was to understand how this drug works in healthy people. Researchers wanted to find out if it was safe, what side effects it might cause, and how the body handles it. They tested different amounts (doses) of the drug and gave it in two ways: either as a drip directly into a vein, or as an injection just under the skin.

The study also aimed to see how the drug affected the body by taking blood samples at different times. This early information is crucial to know before the drug can be tested in people who are actually ill. While this study didn't directly benefit the participants' health, the information gathered is important for potentially developing new treatments for conditions like autoimmune diseases in the future.

Eighty healthy adult men and women took part in this study. They were usually aged between 18 and 65 years old. By studying healthy people, researchers can get a clear picture of the drug's basic safety and how it moves through the body without the complications of existing illnesses. This helps to make sure that future studies in patients can be carried out as safely as possible.

Key takeaways

Researched a new drug (GS-0272) in healthy volunteers.
Aimed to check safety, tolerability, and how the drug acted in the body.
Tested different doses and ways of giving the drug (IV drip or injection).
Involved 80 healthy men and women aged 18-65.
Results could help develop future treatments for autoimmune diseases.
Study ran from May 2022 to May 2024 in South Wales.

Who may be eligible?

To take part in this study, volunteers generally needed to be healthy men or women between 18 and 65 years old. Women were only able to join if they were past menopause or had undergone a procedure that meant they couldn't have children.

Additionally, participants needed to have a healthy weight (Body Mass Index between 18 and 30). They couldn't have any major allergies to the study drug or related substances, and their routine blood and urine tests had to be normal. They also needed to test negative for illegal drugs and certain infections.

Men taking part who had partners who could become pregnant had to agree to use effective contraception (birth control) throughout the study and for three months afterwards to prevent pregnancy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Are you generally healthy, without any major ongoing medical conditions?
If you are a woman, are you past menopause or unable to have children?
Do you have a healthy weight (BMI between 18 and 30)?
Are you able to commit to the study schedule, including an overnight stay and follow-up visits?
Are you willing to use effective birth control if you or your partner could become pregnant?

Answer every question to see your result.

What does participation involve?

If you had joined this study, you would have first had a screening visit to check if you were suitable. Then, for the main part of the study, you would have stayed at the clinic for 6 days with 5 overnight stays.

During this time, you would have received a single dose of the study drug (GS-0272) or a dummy treatment (placebo), either through a drip into your vein or as an injection under your skin. Blood samples would have been taken regularly to see how the drug levels changed in your body and how it affected your system.

After leaving the clinic, you would have returned for 6 more visits over about two months (on days 8, 15, 22, 29, 43, and 57), followed by a final check-up around day 85. The entire study participation, from screening to the final follow-up, would have lasted for several weeks.

Potential risks and benefits

Taking part in this study was not expected to provide direct medical benefits to the participants themselves. However, the information gathered could help researchers develop better treatments for autoimmune diseases in the future. Potential risks included mild pain or bruising from blood tests and injections, temporary discomfort from blood pressure cuffs or ECG sticky pads, and some irritation at the drug injection site. There was also a small risk of COVID-19 exposure due to clinic visits, with safety measures in place. For men, it was important to prevent pregnancy with a partner during and after the study for a period. Throughout the study, participants' health was closely monitored by trained medical staff, and you would have been free to withdraw from the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Simbec Research Limited
City only
Mid Glamorgan, Wales

Common questions

What is GS-0272?

GS-0272 is a new drug being investigated. This study was one of the first times it was given to people.

Why were healthy people used for this study?

Studying healthy volunteers helps researchers understand how the drug works in the body and if it's safe, without other health conditions making things complicated.

Did participants receive any medical treatment for an illness?

No, this study was primarily to gather safety and drug information in healthy individuals, not to treat any specific illness.

How long did the study take for each person?

Participants would have stayed at the clinic for 6 days initially, followed by several return visits over about 2-3 months.

Who paid for this study?

The study was funded and sponsored by an American company called Gilead Science, Inc.

How to find out more

Kanika Chhabra

kanika.chhabra@gilead.com +1 650-653-9339 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.