New drug HSK55879 enters first human safety trial
NCT ID NCT07521345
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 1 study tests the safety and tolerability of a new drug called HSK55879 in 46 healthy adults aged 18 to 45. Participants receive either the drug or a placebo, and researchers monitor side effects and how the drug moves through the body. The goal is to gather early safety data, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK55879
- What could go wrong
- This is a very early Phase 1 study in healthy people, so it cannot show any treatment benefit. The drug may prove unsafe or ineffective in later trials.
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
-
About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- 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 45 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. Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the written informed consent form prior to the start of the study; 2. Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female; 3. Body weight ≥50 kg for male subjects and ≥45 kg for female subjects at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m² (inclusive); 4. Subjects (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use reliable contraceptive measures during this period. Exclusion Criteria: 1. Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study drug, 2. Physical examination, vital signs, laboratory tests,abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be clinically significant abnormalities; 3. Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion; 4. abnormal HbA1c at screening; 5. Abnormal liver function test results 6. Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<90 mL/min/1.73 m² at screening; 7. Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function. 8. History of gastrointestinal diseases, with current symptoms of digestive discomfort ; 9. Current or past history of drug abuse, or a positive urine drug screen at screening; 10. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening; 11. Pregnant or breastfeeding females; 12. Subjects who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this study. \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healhty are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The Second Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could how fast kids chew shape their weight?
- Can a natural compound from moss help the brain? a new trial investigates
- Can a new eye drop pass the safety test?
- Can two experimental drugs be taken together safely? a trial seeks answers
- Morning larks vs night owls: does chronotype shape balance and brain power?
- New portable breath analyzer could bring Lab-Grade fitness testing to the field