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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AK0610 Injection solution
DrugActive Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.
Placebo
DrugActive Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection
Treatment groups
136 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 mlExperimental treatment 2 interventions
Group B: Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 mlExperimental treatment 2 interventions
Group C: Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 mlExperimental treatment 2 interventions
Group D: Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 mlExperimental treatment 2 interventions
Group E: Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 mlExperimental treatment 2 interventions
Group F: Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 mlExperimental treatment 2 interventions
Group G: Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 mlExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (TEAEs)
Capture the incidence and severity of adverse events using CTCAE v5.0, documenting all treatment-emergent adverse events (TEAEs) throughout the study period.
Time frame
Up to 361 daysSecondary outcomes
1
Maximum Observed Serum Concentration (Cmax) of AK0610
The Cmax is the maximum observed serum concentration of AK0610.
Time frame
Up to 361 days2
Time to Reach Maximum Observed Serum Concentration (Tmax) of AK0610
The Tmax is defined as time at which maximum observed concentration of AK0610 (Cmax) was observed.
Time frame
Up to 361 days3
Area Under the serum concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) of AK0610
It represents the area under the curve of serum concentration versus time for the drug AK0610 from the time of administration until the last measurable concentration.
Time frame
Up to 361 days4
Area Under the serum concentration-time curve from time 0 to extrapolated to infinite time (AUC (0-infinity) ) of AK0610
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of AK0610.
Time frame
Up to 361 daysSponsors and contacts
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Source ClinicalTrials.gov