Healthy ParticipantsPhase 1NCT07030790
A Phase I Clinical Study of a Single Dose of KLA480
A Phase 1 study testing KLA480 injection in people with Healthy Participants, run by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. at 1 site in China.
Trial summary
Primary purpose: To evaluate the safety and tolerability of KLA480 injection after a single subcutaneous injection in healthy participants. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of KLA480 injection after a single subcutaneous 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?
- KLA480 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2025to 1 Mar 2027
- 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
- Participants could understand and abide by the study process, voluntarily participate in the study, and sign the informed consent form in person;
- Healthy adult participants of both sexes aged 18 to 45 years (including boundary values);
- A body weight of at least 50.0 kg for men and 45.0 kg for women. BMI in the range of 18.0-28.0 kg/m2 (including the boundary value);
- The results of vital signs, physical examination, laboratory examination, chest X-ray (anteroposterior), and electrocardiogram were normal or abnormal with no clinical significance judged by the investigators;
- Any female or male participant of potential fertility must agree not to donate sperm or eggs from the date of sign informed consent form until 3 months after the last dose, must use an effective contraceptive method, and before the last visit，participants must use nonpharmacologic contraceptive methods to prevent pregnancy or to impregnate a partner.
Who cannot join
- Participants with a history of severe allergy or allergy to any component or vehicle components of rotigotin or other non-ergotamine dopamine agonists (pramipexole, ropinirole, piribedil, and apomorphine) ;
- Participants with a history of gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, tumor, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases with clinical significance judged by the investigators;
- History of unexplained orthostatic hypotension, syncope or low systolic blood pressure;
- Participants with a history of acute infection or other acute diseases within 2 weeks before signing the informed consent form;
- Those who had unprotected sexual behavior within 2 weeks before signing the informed consent form;
- Participants who cannot tolerate venous puncture or have a history of fainting blood or fainting needles;
Show all 23Show fewer
- Donating blood or massive blood loss (≥400 mL), or receiving blood transfusion/use of blood products within 3 months before signing the informed consent form;
- Participants who had undergone surgery that would affect the absorption, distribution, metabolism, or excretion of drug as judged by the investigators within 6 months before signing the informed consent form, or had undergone surgery within 4 weeks before the first dose of the trial drug, or planned to undergo surgery between signing the informed consent form and the last visit;
- Participated in any drug/device clinical trial and used the experimental drug/device within 3 months before signing the informed consent form;
- Those who had been vaccinated within 1 month before signing the informed consent form, or planned to be vaccinated between signing the informed consent form and the last visit;
- Strong or moderate inhibitors and/or inducers of liver metabolic enzymes (CYP1A2, CYP2C19, CYP3A4) of rotigotin was using within 4 weeks before the first dose of the trial drug. Examples: Fluvoxamine, Fluconazole, Fluoxetine, ticlopidine, Ceritinib, atanavir, Adrasib, telithromycin, Clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, indinavir, Nefinavir, ritonavir, Saquinavir, telanavir, Lopinavir, Nefaketozole, Cobirestat, Apalutamide, enzalutamide, Lumacato, Mitol Tam, ivoclib, phenytoin, carbamazepine, rifampicin, St John's wort;
- Who used any prescription drug, over-the-counter drug, vitamin product or Chinese herbal medicine within 2 weeks before the first dose of the trial drug;
- During the screening period, systolic blood pressure decreased ≥20 mmHg or diastolic blood pressure decreased ≥10 mmHg within 3 minutes from supine to upright position, or supine systolic blood pressure < 100 mmHg;
- Participants with QTcF > 450 ms during the screening period;
- Hepatitis B virus surface antigen, hepatitis C virus antibody, TPPA antibody, human immunodeficiency virus antibody test results are positive;
- Female participants with positive pregnancy results or in the lactation period;
- Had a history of drug abuse or drug use within 6 months before signing the informed consent form, or had a positive result of urine drug screening;
- Had a history of heavy drinking within 6 months before signing the informed consent form (heavy drinking was defined as drinking 14 units of alcohol per week: 1 unit = beer 285 mL, or spirits 25 mL, or wine 100 mL), or could not give up drinking from signing the informed consent form to the last visit, or had a positive result of alcohol breath test;
- Participants who had smoked more than 3 cigarettes per day within 3 months before signing the informed consent form, smoked or used tobacco products within 2 weeks before the first dose of the trial drug, or could not give up smoking between signing the informed consent form and the last visit, or had a positive result of tobacco screening test;
- Participants who consumed grapefruit or a drink containing grapefruit juice within 2 weeks before the first dose of the trial drug;
- Those who consumed chocolate, any food or drink containing caffeine (such as coffee, tea, milk tea, cola, red bull, etc.) or rich in xanthine (such as shiitake mushroom, silver carp, mulberry, seafood (silver beetle, white hairtail, oyster, white pomade, eel, etc.), animal organs (duck liver, chicken liver, pig large intestine, pig liver, beef liver, etc.) within 72 hours before the first dose of the trial drug;
- Those who have special dietary requirements and cannot follow the uniform diet during hospitalization;
- Participants with other factors considered by the investigator to be ineligible for the trial.
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
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Jing Zhang, 021-52887926, Zhangj_fudan@163.com
Xiaojie Wu, 021-52887926, maomao_xj@163.com
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-Controlled, Dose Escalation, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of a Single Subcutaneous Injection of KLA480 Injection in Healthy Chinese Participants
Primary purpose:
To evaluate the safety and tolerability of KLA480 injection after a single subcutaneous injection in healthy participants.
Secondary purpose:
To evaluate the pharmacokinetic (PK) characteristics of KLA480 injection after a single subcutaneous injection in healthy participants.
Read the detailed description
This study was a single-center, randomized, double-blind, placebo-controlled, dose Escalation, phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of KLA480 injection after a single subcutaneous injection in healthy Chinese participants.
The plan is to enroll 20 healthy participants in two dose groups: Group I (11.3 mg) and Group II (22.6 mg). Each dose group will includ 10 participants (at least 3 single-sex participants). Among them, 8 participants received the experimental drug KLA480 injection, and 2 participants received the placebo KLA480 injection simulator. Participants in different dose groups were successively enrolled. Based on the evaluation of acceptable tolerance and safety of participants in the former dose group, the researchers will discuss with the sponsor whether to carry out the next dose group. The "sentinel" method was used in each dose group, that is, 3 participants were enrolled in each dose group first, of which 2 participants received KLA480 injection, and 1 participant received placebo KLA480 injection simulator. Tolerance assessment will be performed 48 h after administration of the first 3 participants, and if the tolerance evaluation is acceptable, the remaining 7 participants in the current dose group will be enrolled (6 receiving the experimental drug and 1 receiving placebo).
- Conditions
- Healthy Participants
- Being tested
- KLA480 injection, Placebo
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLA480 injectionDrug
Subcutaneous injection，Single dose
PlaceboDrug
Subcutaneous injection，Single dose
| Study group | Role | What they receive |
|---|---|---|
| KLA480 injection 11.3mg | Experimental | 8 subjects receive KLA480 at a dose of 11.3mg and 2 subjects receive the same volume placebo Receives: Drug: KLA480 injection; Drug: Placebo |
| KLA480 injection 22.6mg | Experimental | 8 subjects receive KLA480 at a dose of 22.6mg and 2 subjects receive the same volume placebo Receives: Drug: KLA480 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability was assessed by the number of participants with adverse events (AE).
Measured: Collected from signing of informed consent until 43 days after a single dose.
Secondary outcomes (5)
Maximum peak plasma concentration (Cmax) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Measured: 43 days after a single dose.
Time of Cmax (tmax) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Measured: 43 days after a single dose.
Area under the concentration-time curve (AUC) from time zero to time "t" [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Measured: 43 days after a single dose.
AUC from time zero to infinity (AUC∞) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Measured: 43 days after a single dose.
Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Measured: 90 days after a single dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start17 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030790
- Sponsor's protocol ID
- KLA480-101
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-Controlled, Dose Escalation, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of a Single Subcutaneous Injection of KLA480 Injection in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07030790
- Acronym / sponsor ID
- KLA480-101
- Conditions
- Healthy Participants
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Jun 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.
Primary purpose:
To evaluate the safety and tolerability of KLA480 injection after a single subcutaneous injection in healthy participants.
Secondary purpose:
To evaluate the pharmacokinetic (PK) characteristics of KLA480 injection after a single subcutaneous injection in healthy participants.
Detailed description
This study was a single-center, randomized, double-blind, placebo-controlled, dose Escalation, phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of KLA480 injection after a single subcutaneous injection in healthy Chinese participants.
The plan is to enroll 20 healthy participants in two dose groups: Group I (11.3 mg) and Group II (22.6 mg). Each dose group will includ 10 participants (at least 3 single-sex participants). Among them, 8 participants received the experimental drug KLA480 injection, and 2 participants received the placebo KLA480 injection simulator. Participants in different dose groups were successively enrolled. Based on the evaluation of acceptable tolerance and safety of participants in the former dose group, the researchers will discuss with the sponsor whether to carry out the next dose group. The "sentinel" method was used in each dose group, that is, 3 participants were enrolled in each dose group first, of which 2 participants received KLA480 injection, and 1 participant received placebo KLA480 injection simulator. Tolerance assessment will be performed 48 h after administration of the first 3 participants, and if the tolerance evaluation is acceptable, the remaining 7 participants in the current dose group will be enrolled (6 receiving the experimental drug and 1 receiving placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KLA480 injection 11.3mg | Experimental | Drug: KLA480 injection, Drug: Placebo8 subjects receive KLA480 at a dose of 11.3mg and 2 subjects receive the same volume placebo |
| KLA480 injection 22.6mg | Experimental | Drug: KLA480 injection, Drug: Placebo8 subjects receive KLA480 at a dose of 22.6mg and 2 subjects receive the same volume placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants could understand and abide by the study process, voluntarily participate in the study, and sign the informed consent form in person;
- Healthy adult participants of both sexes aged 18 to 45 years (including boundary values);
- A body weight of at least 50.0 kg for men and 45.0 kg for women. BMI in the range of 18.0-28.0 kg/m2 (including the boundary value);
- The results of vital signs, physical examination, laboratory examination, chest X-ray (anteroposterior), and electrocardiogram were normal or abnormal with no clinical significance judged by the investigators;
- Any female or male participant of potential fertility must agree not to donate sperm or eggs from the date of sign informed consent form until 3 months after the last dose, must use an effective contraceptive method, and before the last visit，participants must use nonpharmacologic contraceptive methods to prevent pregnancy or to impregnate a partner.
Key exclusion criteria (23 listed)
- Participants with a history of severe allergy or allergy to any component or vehicle components of rotigotin or other non-ergotamine dopamine agonists (pramipexole, ropinirole, piribedil, and apomorphine) ;
- Participants with a history of gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, tumor, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases with clinical significance judged by the investigators;
- History of unexplained orthostatic hypotension, syncope or low systolic blood pressure;
- Participants with a history of acute infection or other acute diseases within 2 weeks before signing the informed consent form;
- Those who had unprotected sexual behavior within 2 weeks before signing the informed consent form;
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 |
|---|---|---|
| KLA480 injectionSubcutaneous injection，Single dose | Drug | KLA480 injection 11.3mg, KLA480 injection 22.6mg |
| PlaceboSubcutaneous injection，Single dose | Drug | KLA480 injection 11.3mg, KLA480 injection 22.6mg |
Primary outcome
Safety and tolerability
Time frame: Collected from signing of informed consent until 43 days after a single dose.
Safety and tolerability was assessed by the number of participants with adverse events (AE).
5 secondary outcomes
Maximum peak plasma concentration (Cmax) [Pharmacokinetics]
Time frame: 43 days after a single dose.
Time of Cmax (tmax) [Pharmacokinetics]
Time frame: 43 days after a single dose.
Area under the concentration-time curve (AUC) from time zero to time "t" [Pharmacokinetics]
Time frame: 43 days after a single dose.
AUC from time zero to infinity (AUC∞) [Pharmacokinetics]
Time frame: 43 days after a single dose.
Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics]
Time frame: 90 days after a single dose.
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 22 Jun 2025.
- 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 KLA480 injection in people with Healthy Participants, run by Sichuan Kelun Pharmaceutical Research Institute 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 5 inclusion and 23 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 22 Jun 2025. 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?
Safety and tolerability (time frame: Collected from signing of informed consent until 43 days after a single dose.). 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 22 Jun 2025.