A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects

Shanghai Ark Biopharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AK3280; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03990688

AK3280-4001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

AK3280 (Cohort 1)

Experimental group

Description:

Subjects in Cohort 1 are administered with an oral dose of 100 mg AK3280 b.i.d from Day 1 to Day 14.

Treatment:

Drug: AK3280

AK3280 (Cohort 2)

Experimental group

Description:

Subjects in Cohort 2 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 2 will be based on the emerging data from previous cohort.

Treatment:

Drug: AK3280

AK3280 (Cohort 3)

Experimental group

Description:

Subjects in Cohort 3 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 3 will be based on the emerging data from previous cohorts.

Treatment:

Drug: AK3280

Placebo

Placebo Comparator group

Description:

For assessment of the Adverse Event (AE) profile, there are placebo controls in each dose cohort.

Treatment:

Drug: Placebo