Bridging Study of XKH001 in Healthy Adult Caucasian Participants
ConditionHealthy Adult
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhejiang Kanova Biopharmaceutical Co., LTD
About this trial
This is a Phase Id, randomised, double-blind, placebo-controlled, multiple-dose, bridging study conducted at a single Phase I clinical research unit in Australia. The study is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of XKH001 following repeated subcutaneous administration in healthy adult Caucasian participants, and to provide an ethnic-bridging pharmacokinetic comparison with the prior Phase I dataset in Chinese participants, required for XKH001's global development programme.
Eligibility criteria
Qualifiers
Healthy participants who voluntarily provide written informed consent and can comply with all study procedures according to the protocol.
Male or female participants of Caucasian ethnicity(both biological parents and all four grandparents of Caucasian origin), 18-65 years of age (inclusive).
Body mass index (BMI) between 18.0-32.0 kg/m² (inclusive).
Vital signs, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) within normal limits or considered not clinically significant by the investigator, with QTcF ≤450 ms.
Disqualifiers
Pregnant or breastfeeding women.
Any clinically significant disease within 5 years that could affect participation (gastrointestinal, renal, hepatic, pulmonary, neurology, Haematology, endocrine, oncology, metabolic, psychiatric, or cerebrovascular).
History of autoimmune disease, known hereditary immunodeficiency, or recurrent infections suggesting immunodeficiency.
Active infection requiring hospitalisation or IV antibiotics within 3 months, or clinically symptomatic bacterial, viral, or fungal infection within 4 weeks prior to first dosing.
Trial design
Treatments tested in this trial
- XKH001 Injection
- XKH001 Placebo Injection
Treatment groups
2 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov