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

NCT03990688 | Completed Phase 1 DMC

• 1 other identifier: AK3280-4001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Directly measured absolute glomerular filtration rate (mGFR) results.

  The effect of AK3280 treatment on GFR is measured by iohexol plasma clearance.

  Days -1, 7, and 14.

• Change from baseline mGFR results.

  To compare the difference of effect of AK3280 treatment on GFR.

  Days 7 and 14.

Secondary Outcomes (8)

• Frequency, intensity, and seriousness of Adverse Events (AEs)

  From Day -1 to Day 28.

• Change in blood renal function biomarkers

  Screening, Days -2, 7, 14, and 21.

• Change in urine renal function biomarkers

  From Day -1 to Day 21.

• Maximum Observed Plasma Concentration (Cmax)

  Days 1, 7, and 14.

• Concentration at the end of the dosing interval (Ctau)

  Days 1, 7, and 14.

Study Arms (4)

AK3280 (Cohort 1)

EXPERIMENTAL

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

Drug: AK3280

AK3280 (Cohort 2)

EXPERIMENTAL

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.

Drug: AK3280

AK3280 (Cohort 3)

EXPERIMENTAL

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.

Drug: AK3280

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AK3280 DRUG

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

AK3280 (Cohort 1); AK3280 (Cohort 2); AK3280 (Cohort 3)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

CTC Clinical Trial Consultants AB

Uppsala, Sweden

Location

Study Officials

• Jimmy Gu

  info@arkbiosciences.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 19, 2019
• Study Start: October 3, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 21, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)