Clinical trial NCT03990688: A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Multiple Oral Doses of AK3280 on Renal Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Willing and able to give full written informed consent for participation in the study.
* Healthy male or female subject aged 18-45 years inclusive.
* Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2。
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator in agreement with the Medical Monitor.
* With normal renal function defined as mean plasma eGFR ≥80 mL/min/1.73 m2 at screening.
* Male subjects and applicable female subjects must agree to use effective contraceptive methods to prevent drug exposure of a partner and pregnancy.

Exclusion Criteria:

* History of allergy to iohexol or other contrast media, to iodine or to shellfish.
* History of any clinically significant disease or disorder or any other condition that in the opinion of the Investigator renders them unsuitable to participate in the study.
* Regular use of any prescribed or non-prescribed medication within two weeks prior to the (first) administration of IMP.
* Any significant elevation at screening or on Day -2 of liver or urinary or serum or plasma renal test results.
* Subjects with poor venous access.
* Subjects who have smoked cigarettes (including vapour cigarettes), cigars, and/or used nicotine-containing products within 3 months prior to their screening visit.
* Positive screen for a drug of abuse or alcohol at screening or prior to administration of the IMP.
* Subjects who have not abstained from caffeine-containing beverages or products from at least 48 hours prior to screening.
* An abnormal diet within the 30 days prior to the first study drug dose.
* Any use of protein powders, xanthine and/or taurine containing energy drinks within 48 hours prior to screening.
* Blood donation (or corresponding blood loss) during the three months prior to screening.
* Employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
* Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Primary outcomes:
measure: Directly measured absolute glomerular filtration rate (mGFR) results.
timeFrame: Days -1, 7, and 14.
measure: Change from baseline mGFR results.
timeFrame: Days 7 and 14.
Secondary outcomes:
measure: Frequency, intensity, and seriousness of Adverse Events (AEs)
timeFrame: From Day -1 to Day 28.
measure: Change in blood renal function biomarkers
timeFrame: Screening, Days -2, 7, 14, and 21.
measure: Change in urine renal function biomarkers
timeFrame: From Day -1 to Day 21.
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Days 1, 7, and 14.
measure: Concentration at the end of the dosing interval (Ctau)
timeFrame: Days 1, 7, and 14.
measure: trough plasma concentration (Ctrough)
timeFrame: Days 1, 7 and 14.
measure: trough plasma concentration (Ctrough)
timeFrame: Days 1, 7, and 14.
measure: Area under the plasma concentration-time curve from time zero up to time (AUC 0-t)
timeFrame: Days 1, 7, and 14.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
Study officials:
affiliation: info@arkbiosciences.com
name: Jimmy Gu
role: STUDY_DIRECTOR
References: