RecruitingPhase 1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers

China76 participantsStarted 2026-03-02

Plain-language summary

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able to understand the purpose, content, procedures, and possible risks of the trial,willing to participate and sign the informed consent;
. Volunteers aged 18-45 years (inclusive) at the time of signing the informed consent,no gender limit;
. 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);
. 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;
. 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

. 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;
. History of anesthesia accident, serious adverse reaction to anesthesia or family history of anesthesia accident prior to screening;
. 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；

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of reported Adverse Events

Timeframe: From first dose of drug until day 2

Trial details

NCT IDNCT07474545

SponsorHunan Kelun Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Wei Qi

028-82339360 qiw@kelun.com

View on ClinicalTrials.gov More Healthy Volunteers trials