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

NCT ID: NCT03990688

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-03
• Study Completion Date: 2020-09-21

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AK3280 (Cohort 1)

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

Group Type: EXPERIMENTAL

AK3280

Intervention Type: DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

AK3280 (Cohort 2)

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.

Group Type: EXPERIMENTAL

AK3280

Intervention Type: DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

AK3280 (Cohort 3)

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.

Group Type: EXPERIMENTAL

AK3280

Intervention Type: DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Interventions

AK3280

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

Intervention Type: DRUG

Placebo

Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ark Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jimmy Gu

Role: STUDY_DIRECTOR

info@arkbiosciences.com

Locations

CTC Clinical Trial Consultants AB

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

AK3280-4001

Identifier Type: -

Identifier Source: org_study_id