One shot instead of many? a cholesterol drug puts simplicity to the test
NCT ID NCT06837077
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial investigates whether a single injection of the experimental drug SHR-1209 can replace multiple injections for lowering cholesterol. Healthy volunteers aged 18 to 55 will receive both single-site and multiple-site injections in a crossover design to compare pain, safety, and how the drug moves through the body. The goal is to see if a simpler injection method could make long-term cholesterol control easier for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental injectable drug called SHR-1209
- What this could lead to
- If successful, this could simplify cholesterol treatment to a single injection per dose, improving convenience and long-term disease control.
- What could go wrong
- This is an early-phase trial in healthy volunteers, not patients, so results may not translate directly to real-world use. The drug may still cause side effects or fail to show benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
49 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent; 2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old; 3. Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and \<28.0 kg/m2, weight of male must≥ 50.0 kg and \<90.0 kg, and female≥ 45.0 kg and \<90.0 kg; 4. The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum. Exclusion Criteria: 1. Serious infection within 3 months before screening; 2. History of food or drug allergy or atopic allergic disease (asthma, urticaria); 3. Positive blood pregnancy test; 4. Have a history of drug abuse; 5. Women who are pregnant or breastfeeding; 6. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hypercholesterolemia and hyperlipidemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of USTC
Hefei, Anhui, 230000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.