A Clinical Study of AK0610
ConditionHealthy Volunteer Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Ark Biopharmaceutical Co., Ltd.
About this trial
The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.
Eligibility criteria
Qualifiers
Participants aged 18 - 50 (both males and females)
Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg/m2.
Assessed by the investigator to be in good health with no clinically significant abnormalities.
Use of highly effective contraception within 1 year of administration.
Disqualifiers
Clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric system disorders, or any other condition that, in the opinion of the Investigator, may jeopardize subject safety or validity of the study results, or that may result in the inability of the subject to complete the study in accordance with the protocol.
Active malignancy and/or a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)
History of congenital or acquired immunodeficiency.
Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.
Trial design
Treatments tested in this trial
- AK0610 Injection solution
- Placebo
Treatment groups
136 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov