Healthy VolunteersPhase 1NCT07240675
Single-dose,First-in-human of KLA478
A Phase 1 study testing pramipexole hydrochloride sustained-release tablets and KLA478 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 doses of KLA478 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?
- pramipexole hydrochloride sustained-release tablets and KLA478
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2025to 30 Sep 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
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 28.0kg/m2;
- Clinical examination normal, or abnormal with no clinical significance；
- Agreed to use contraception for 3-6 months.
Who cannot join
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History；
- Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia；
- Assess injection site abnormalities；
- History of drugs that may interact with pramipexole within 1 month；
- History of any Medication within 2 weeks；
Show all 24Show fewer
- Massive blood loss (> 200 mL) in the past 3 months；
- History of any surgery within 3 months, or plan to undergo surgery during the trial；
- History of any clinical study within 90 days；
- History of any vaccine within 1 month，or Plan to get vaccinated during the trial period；
- systolic blood pressure decreased ≥20 mmHg or diastolic blood pressure decreased ≥10 mmHg within 3 minutes from supine to upright position；
- QTcF>450 ms；
- Abnormal vital signs with clinical significance ；
- Serum potassium level exceeds the reference range.；
- Pre-transfusion test abnormal；
- Lactation or pregnancy test positive ；
- History of any drug abuse or positive drugs of abuse test result；
- Previous alcohol abuse or unwillingness to stop drinking or alcohol breath test positive；
- more than 3 cigarettes per day in 3 months, or unwilling to stop during the trial；
- Intake of special diets that affect drug absorption, distribution, metabolism and excretion within 48 hours；
- Have special requirements for diet；
- Unprotected sexual behavior within 2 weeks;
- engaged in driving vehicles, operating machinery, high-altitude work or other potentially dangerous behavior;
- Inappropriate for participation in this trial as judged by the investigator.
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, 201107
Jing Zhang, 13816357098, 13816357098@163.com
Xiaojie Wu, 13524686330, maomao_xj@163.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of KLA478 in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；
Read the detailed description
This study is a single-center, randomized/non-randomized, single ascending dose（SAD）, Phase I clinical trial conducted in healthy subjects, divided into two parts:
Part 1 is an open-label single-dose study of active comparator to evaluate the pharmacokinetic characteristics of active comparator in healthy subjects； Part 2 is a randomized, double-blind, placebo-controlled single ascending dose study of KLA478: The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；
- Conditions
- Healthy Volunteers
- Being tested
- pramipexole hydrochloride sustained-release tablets, KLA478, placebo
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramipexole hydrochloride sustained-release tabletsDrug
P.O., single dose
KLA478Drug
intramuscular injection, single dose
placeboDrug
intramuscular injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| pramipexole hydrochloride sustained-release tablets 0.375mg | Active comparator | 10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg Receives: Drug: pramipexole hydrochloride sustained-release tablets |
| KLA478 2mg | Experimental | 8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo Receives: Drug: KLA478; Drug: placebo |
| KLA478 5mg | Experimental | 8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo Receives: Drug: KLA478; Drug: placebo |
| KLA478 10mg | Experimental | 8 volunteers receive KLA478 10mg，2 volunteers receive the same volume placebo Receives: Drug: KLA478; Drug: placebo |
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 109
Secondary outcomes (11)
PK parameter Tmax
Time of Cmax (Tmax) after single dose
Measured: up to Day 90
PK parameter Cmax
Maximum peak plasma concentration (Cmax) after single dose
Measured: up to Day 90
PK parameter AUC0-t
Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose
Measured: up to Day 90
PK parameter AUC0-∞
AUC from time zero to infinity (AUC0-∞) after single dose
Measured: up to Day 90
PK parameter AUC_%Extrap
Area Under the Curve Percent Extrapolated
Measured: up to Day 90
PK parameter Tlast
Time of Last measurable concentration
Measured: Area Under the Curve Percent Extrapolated
PK parameter λz
Elimination Rate Constant
Measured: up to Day 90
PK parameter t1/2
Terminal-phase elimination half-life (t1/2) after single dose
Measured: up to Day 90
PK parameter CL/F
Clearance adjusted for bioavailability
Measured: up to Day 90
PK parameter Vz/F
Volume of Distribution adjusted for bioavailability
Measured: up to Day 90
PK parameter MRT
Mean Resident Time
Measured: up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start26 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT07240675
- Sponsor's protocol ID
- KLA478-101
- Status last verified
- May 2026
- First submitted
- 14 Nov 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 Doses of KLA478 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07240675
- Acronym / sponsor ID
- KLA478-101
- Conditions
- Healthy Volunteers
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Nov 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 doses of KLA478 in healthy volunteers；
Detailed description
This study is a single-center, randomized/non-randomized, single ascending dose（SAD）, Phase I clinical trial conducted in healthy subjects, divided into two parts:
Part 1 is an open-label single-dose study of active comparator to evaluate the pharmacokinetic characteristics of active comparator in healthy subjects； Part 2 is a randomized, double-blind, placebo-controlled single ascending dose study of KLA478: The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pramipexole hydrochloride sustained-release tablets 0.375mg | Active comparator | Drug: pramipexole hydrochloride sustained-release tablets10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg |
| KLA478 2mg | Experimental | Drug: KLA478, Drug: placebo8 volunteers receive KLA478 2mg，2 volunteers receive the same volume placebo |
| KLA478 5mg | Experimental | Drug: KLA478, Drug: placebo8 volunteers receive KLA478 5mg，2 volunteers receive the same volume placebo |
| KLA478 10mg | Experimental | Drug: KLA478, Drug: placebo8 volunteers receive KLA478 10mg，2 volunteers 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)
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 28.0kg/m2;
- Clinical examination normal, or abnormal with no clinical significance；
- Agreed to use contraception for 3-6 months.
Key exclusion criteria (24 listed)
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History；
- Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia；
- Assess injection site abnormalities；
- History of drugs that may interact with pramipexole within 1 month；
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 |
|---|---|---|
| pramipexole hydrochloride sustained-release tabletsP.O., single dose | Drug | pramipexole hydrochloride sustained-release tablets 0.375mg |
| KLA478intramuscular injection, single dose | Drug | KLA478 10mg, KLA478 2mg, KLA478 5mg |
| placebointramuscular injection, single dose | Drug | KLA478 10mg, KLA478 2mg, KLA478 5mg |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to Day 109
11 secondary outcomes
PK parameter Tmax
Time frame: up to Day 90
PK parameter Cmax
Time frame: up to Day 90
PK parameter AUC0-t
Time frame: up to Day 90
PK parameter AUC0-∞
Time frame: up to Day 90
PK parameter AUC_%Extrap
Time frame: up to Day 90
PK parameter Tlast
Time frame: Area Under the Curve Percent Extrapolated
PK parameter λz
Time frame: up to Day 90
PK parameter t1/2
Time frame: up to Day 90
PK parameter CL/F
Time frame: up to Day 90
PK parameter Vz/F
Time frame: up to Day 90
PK parameter MRT
Time frame: up to Day 90
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 pramipexole hydrochloride sustained-release tablets and KLA478 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 5 inclusion and 24 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 109). 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.