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New cholesterol drug passes early safety check in healthy volunteers

NCT ID NCT06857253

Disease control Sponsor: Shandong Suncadia Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called HRS-1301 in 82 healthy adults to check its safety and how the body processes it. The goal is to see if it can help control high cholesterol. Participants received either the drug or a placebo, and researchers monitored for side effects and drug levels in blood and urine.

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

82 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male and female subjects must be at least 18 years old and no more than 55 years old on the date of signing the ICF. 2. The female subjects must be non-pregnant or non-childbearing potential. 3. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person. Exclusion Criteria: 1. Have a gastrointestinal, liver or kidney disease or other condition known to affect drug absorption, distribution, metabolism and excretion or to reduce adherence, as determined by the investigator. 2. Those who had severe trauma or had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the trial. 3. Have a history of repeated drug allergies. 4. People who have used any drug in the 2 weeks prior to screening. 5. Those who received live (attenuated) vaccine within 4 weeks prior to screening or planned to receive it during the trial.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemia

Contacts and locations

Locations

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.