NCT03990688

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	AK3280	Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
DRUG	Placebo	Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Timeline

• Start date: 2019-10-03
• Primary completion: 2020-09-09
• Completion: 2020-09-21
• First posted: 2019-06-19
• Last updated: 2021-06-09

Locations

1 site across 1 country: Sweden