Healthy ParticipantsPhase 1NCT07171034
A Phase I Study of KLA318-2 Nanocrystal Injection
A Phase 1 study testing KLA318-2 Nanocrystal Injection and Celebrex Capsule in people with Healthy Participants, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- KLA318-2 Nanocrystal Injection and Celebrex Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;
- Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
Who cannot join
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- Gastrointestinal ulcers or gastrointestinal bleeding;
- History of any surgery within 4 weeks;
- History of any Medication within 14 days;
- History of any drug interactions with celecoxib within 30 days;
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- History of any clinical study within 3 months;
- History of any vaccine within 1 month;
- History of any drug abuse, or positive drugs of abuse test result;
- Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
- Massive blood loss (> 200 mL) in the past 3 months;
- Special requirements for diet;
- Heavy smoker ( more than 3 cigarettes/day) within 3 months;
- History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 7 days;
- Female participants are pregnant or lactating;
- History of unprotected sex within 2 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014
Wei Zhao, 0531-89268212, zhao4wei2@hotmail.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants
The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- KLA318-2 Nanocrystal Injection, Celebrex Capsule
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLA318-2 Nanocrystal InjectionDrug
Intravenous injection, single dose
Celebrex CapsuleDrug
P.O., single dose
| Study group | Role | What they receive |
|---|---|---|
| KLA318-2 Nanocrystal Injection 60mg | Experimental | 12 participants receive KLA318-2 60mg Receives: Drug: KLA318-2 Nanocrystal Injection |
| KLA318-2 Nanocrystal Injection 120mg | Active comparator | Period 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg Receives: Drug: KLA318-2 Nanocrystal Injection; Drug: Celebrex Capsule |
| KLA318-2 Nanocrystal Injection 180mg | Active comparator | Period 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg Receives: Drug: KLA318-2 Nanocrystal Injection; Drug: Celebrex Capsule |
| KLA318-2 Nanocrystal Injection 240mg | Experimental | 12 participants receive KLA318-2 240mg Receives: Drug: KLA318-2 Nanocrystal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: UP to Day 14
Secondary outcomes (5)
PK parameter Cmax
Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses
Measured: UP to Day 3
PK parameter Tmax
Time of Cmax (Tmax) after single dose and in a steady state after multiple doses
Measured: UP to Day 3
PK parameter AUC0-t
Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose and in a steady state after multiple doses
Measured: UP to Day 3
PK parameter AUC0-∞
AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses
Measured: UP to Day 3
PK parameter t1/2
Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses
Measured: UP to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Sep 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171034
- Sponsor's protocol ID
- KLA318-2-101
- Status last verified
- May 2026
- First submitted
- 28 Aug 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT07171034
- Acronym / sponsor ID
- KLA318-2-101
- Conditions
- Healthy Participants
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KLA318-2 Nanocrystal Injection 60mg | Experimental | Drug: KLA318-2 Nanocrystal Injection12 participants receive KLA318-2 60mg |
| KLA318-2 Nanocrystal Injection 120mg | Active comparator | Drug: KLA318-2 Nanocrystal Injection, Drug: Celebrex CapsulePeriod 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg |
| KLA318-2 Nanocrystal Injection 180mg | Active comparator | Drug: KLA318-2 Nanocrystal Injection, Drug: Celebrex CapsulePeriod 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg |
| KLA318-2 Nanocrystal Injection 240mg | Experimental | Drug: KLA318-2 Nanocrystal Injection12 participants receive KLA318-2 240mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;
- Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
Key exclusion criteria (18 listed)
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- Gastrointestinal ulcers or gastrointestinal bleeding;
- History of any surgery within 4 weeks;
- History of any Medication within 14 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLA318-2 Nanocrystal InjectionIntravenous injection, single dose | Drug | KLA318-2 Nanocrystal Injection 120mg, KLA318-2 Nanocrystal Injection 180mg, KLA318-2 Nanocrystal Injection 240mg, KLA318-2 Nanocrystal Injection 60mg |
| Celebrex CapsuleP.O., single dose | Drug | KLA318-2 Nanocrystal Injection 120mg, KLA318-2 Nanocrystal Injection 180mg |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: UP to Day 14
5 secondary outcomes
PK parameter Cmax
Time frame: UP to Day 3
PK parameter Tmax
Time frame: UP to Day 3
PK parameter AUC0-t
Time frame: UP to Day 3
PK parameter AUC0-∞
Time frame: UP to Day 3
PK parameter t1/2
Time frame: UP to Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KLA318-2 Nanocrystal Injection and Celebrex Capsule in people with Healthy Participants, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Qi (028-82339360, qiw@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: UP to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.