A Phase I Clinical Study of a Single Dose of KLA480

NCT07030790 | Recruiting Phase 1

• 1 other identifier: KLA480-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability was assessed by the number of participants with adverse events (AE).

  Collected from signing of informed consent until 43 days after a single dose.

Secondary Outcomes (5)

• Maximum peak plasma concentration (Cmax) [Pharmacokinetics]

  43 days after a single dose.

• Time of Cmax (tmax) [Pharmacokinetics]

  43 days after a single dose.

• Area under the concentration-time curve (AUC) from time zero to time "t" [Pharmacokinetics]

  43 days after a single dose.

• AUC from time zero to infinity (AUC∞) [Pharmacokinetics]

  43 days after a single dose.

• Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics]

  90 days after a single dose.

Study Arms (2)

KLA480 injection 11.3mg

EXPERIMENTAL

8 subjects receive KLA480 at a dose of 11.3mg and 2 subjects receive the same volume placebo

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

Drug: KLA480 injection; Drug: Placebo

Interventions

KLA480 injection DRUG

Subcutaneous injection，Single dose

KLA480 injection 11.3mg; KLA480 injection 22.6mg

Placebo DRUG

Subcutaneous injection，Single dose

KLA480 injection 11.3mg; KLA480 injection 22.6mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

Wei Qi

CONTACT

028-82339360; qiw@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: May 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)