Healthy VolunteersPhase 1NCT07143318
First-in-Human Single and Multiple Dose of KLA578-1 for Injection
A Phase 1 study testing KLA578-1 for injection and Etopcoxib Tablets in people with Healthy Volunteers, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- KLA578-1 for injection and Etopcoxib Tablets
- 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
- 5 Jun 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 Volunteers (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
- There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;
- Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.
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 inducers or inhibitors of major CYP450 enzymes within 30 days;
Show all 21Show fewer
- History of any clinical study within 3 months;
- History of any vaccine within 1 month;
- History of any drug abuse;
- Tablet dysphagia;
- Needle sickness, Hematosickness;
- Massive blood loss (> 200 mL) in the past 3 months;
- Female volunteers are pregnant or lactating;
- History of unprotected sex within 2 weeks;
- 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;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 7 days;
- Positive alcohol test;
- Positive drugs of abuse test result.
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 Third Xiangya Hospital of Central South University
Changsha, Hunan, 611130
Guoping Yang, 13974817168, ygp9880@163.com
Chengxian Guo, 15580992599, gchxyy@163.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers
Read the detailed description
"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence.
Part 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."
- Conditions
- Healthy Volunteers
- Being tested
- KLA578-1 for injection, Etopcoxib Tablets
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLA578-1 for injectionDrug
Intravenous injection, single dose
Etopcoxib TabletsDrug
P.O., single dose
| Study group | Role | What they receive |
|---|---|---|
| KLA578-1 60mg | Experimental | 12 volunteers receive KLA578-1 for injection 60mg Receives: Drug: KLA578-1 for injection |
| KLA578-1 120mg | Active comparator | Period 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg Receives: Drug: KLA578-1 for injection; Drug: Etopcoxib Tablets |
| KLA578-1 240mg | Experimental | 12 volunteers receive KLA578-1 for injection 240mg Receives: Drug: KLA578-1 for injection |
| multiple doses of KLA578-1 for injection | Experimental | 12 volunteers receive KLA578-1 for injection 120mg over 5 consecutive days. Receives: Drug: KLA578-1 for 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 13
Secondary outcomes (7)
PK parameter Cmax
Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses
Measured: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter Tmax
Time of Cmax (Tmax) after single dose and in a steady state after multiple doses
Measured: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter Cmin,ss
The trough concentration observed during the drug administration interval in a steady state (Cmin,ss) after multiple doses
Measured: multiple doses: up to Day 1
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: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter AUC0-∞
AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses
Measured: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter AUCtau,ss
AUC for the drug administration interval in a steady state (AUCtau,ss) after multiple doses
Measured: multiple doses: up to Day 1
PK parameter t1/2
Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses
Measured: single dose：up to Day 6 ; multiple doses: up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start5 Jun 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 VolunteersStudies 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
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT07143318
- Sponsor's protocol ID
- KLA578-1-101
- Status last verified
- May 2026
- First submitted
- 23 Jul 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 Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07143318
- Acronym / sponsor ID
- KLA578-1-101
- Conditions
- Healthy Volunteers
- 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
- 5 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Aug 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 and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers
Detailed description
"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence.
Part 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KLA578-1 60mg | Experimental | Drug: KLA578-1 for injection12 volunteers receive KLA578-1 for injection 60mg |
| KLA578-1 120mg | Active comparator | Drug: KLA578-1 for injection, Drug: Etopcoxib TabletsPeriod 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg |
| KLA578-1 240mg | Experimental | Drug: KLA578-1 for injection12 volunteers receive KLA578-1 for injection 240mg |
| multiple doses of KLA578-1 for injection | Experimental | Drug: KLA578-1 for injection12 volunteers receive KLA578-1 for injection 120mg over 5 consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Health Volunteers (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
- There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;
- Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.
Key exclusion criteria (21 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 |
|---|---|---|
| KLA578-1 for injectionIntravenous injection, single dose | Drug | KLA578-1 120mg, KLA578-1 240mg, KLA578-1 60mg, multiple doses of KLA578-1 for injection |
| Etopcoxib TabletsP.O., single dose | Drug | KLA578-1 120mg |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to day 13
7 secondary outcomes
PK parameter Cmax
Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter Tmax
Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter Cmin,ss
Time frame: multiple doses: up to Day 1
PK parameter AUC0-t
Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter AUC0-∞
Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8
PK parameter AUCtau,ss
Time frame: multiple doses: up to Day 1
PK parameter t1/2
Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8
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 KLA578-1 for injection and Etopcoxib Tablets in people with Healthy Volunteers, 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 4 inclusion and 21 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 13). 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.