Healthy volunteers needed to test experimental Injection's safety
NCT ID NCT07474545
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a single dose of an experimental drug called KL0011034 in 76 healthy Chinese volunteers aged 18-45. The main goal is to check for side effects and how the drug moves through the body. Participants are randomly assigned to receive the drug, a placebo, or an active comparator. No direct health benefit is expected, but results will guide future research.
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 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Dec 2027
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 purpose, content, procedures, and possible risks of the trial,willing to participate and sign the informed consent; 2. Volunteers aged 18-45 years (inclusive) at the time of signing the informed consent,no gender limit; 3. The body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive); 4. Agree not to conceive or father a child (and ensure their partners of childbearing potential do not conceive) and agree not to donate gametes from signing informed consent through 3 months after dosing; Agree to use effective contraception during this period; 5. Able to communicate well with the investigator, and willing to comply with the protocol restrictions, and cooperate with the completion of the trial process. Exclusion Criteria: 1. The investigator considers that the volunteer has any current or past medical condition (including but not limited to disorders of the central nervous, cardiovascular, endocrine, respiratory, digestive, urinary, hematological, or lymphatic systems) that may interfere with the trial; 2. History of anesthesia accident, serious adverse reaction to anesthesia or family history of anesthesia accident prior to screening; 3. History of difficult mask ventilation, difficult intubation, or anticipated difficult airway management prior to screening, including but not limited to modified Mallampati score III-IV, bifid or absent uvula, micrognathia, or retrognathia; 4. History of asthma, COPD, or obstructive sleep apnea; or current respiratory disease prior to screening; 5. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria prior to screening; 6. Clinically significant abnormalities in physical examination, vital signs, chest X-ray, abdominal ultrasound, or clinical laboratory tests; or abnormal circadian rhythm of cortisol or ACTH deemed clinically significant by the investigator; 7. Clinically significant ECG abnormalities at screening, including QTcF≥ 450 ms (men) or ≥ 460 ms (female); 8. Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody at screening; 9. Pregnancy or lactation at screening; or positive pregnancy test for females of childbearing potential; 10. Known history of drug or alcohol abuse or dependence within 12 months prior to screening, or positive urine drug test at screening; 11. Alcohol abuse within 6 months prior to screening, positive breath alcohol test at screening, or unwillingness to abstain from alcohol during the trail; 12. Positive urine cotinine test at screening, or history of regular smoking (≥5 cigarettes/day) within 6 months prior to screening, or unwillingness to abstain from tobacco use during the trial; 13. Habitual consumption of \>8 cups/day of tea, coffee, or other caffeinated beverages (1 cup ≈ 250 mL) prior to screening, or unwillingness to abstain from the above beverages during the trial; 14. Use of any medications within the past 14 days, including prescription and over-the-counter medications, traditional Chinese medicine, health care products, and vitamins; 15. Known allergy to etomidate or other anesthetics;or atopy (defined as allergy to ≥2 medications, foods, or pollen);or prone to developing rashes or hives; or history of allergic diseases;or known allergy to the excipients or active pharmaceutical ingredients; 16. Participation in any clinical trial within 3 months prior to screening, or failure to complete the follow-up period of a previous trial; 17. Vaccination within 1 month (inactivated) or 3 months (live) prior to screening, or intent to receive any vaccine dinactivated/live/attenuated vaccine during the trial; 18. Blood donation, or blood transfusion, or significant blood loss (\>400 ml) within 3 months prior to screening; or planned blood donation or surgery during the trail or within 1 month after the trial; 19. Surgery within 3 months prior to screening, ongoing post-surgical recovery, or planned surgical procedure during the trial; 20. Difficulty in collecting blood, unable to tolerate venipuncture and/or having a history of haemorrhage or needle halo; 21. Volunteers with unprotected sexual intercourse within 2 weeks before administration; 22. Poor compliance,or any other circumstance deemed by the investigator to contraindicate participation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers 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 Third XIANGYA Hospital of Central South University
RECRUITINGChangsha, Hunan, 410205, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe the nerve highways behind strength gains
- New syphilis test kits put to the test with donated blood
- Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people
- Novo nordisk tests Brand-New molecule in humans for the first time
- New sedative candidate goes Head-to-Head with propofol in early human test
- Can a Room-Temperature dairy drink build muscle?