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A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers

NCT03322800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-06-09

No results posted yet for this study

Summary

This study will characterize the pharmacokinetics (PK) of AK0529, the effect of food and evaluate the safety of AK0529 in healthy Chinese adult subjects. 50 subjects will be randomized to receive a dose level of AK0529 or placebo in five groups. The total study duration will be approximately 18-27 days for each subject.

Conditions

  • Healthy

Interventions

DRUG

AK0529

Active Substance: AK0529, Pharmaceutical Form: Capsule, Route of Administration: Oral

OTHER

Placebo

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

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2018-04-06
Completion
2018-05-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03322800 on ClinicalTrials.gov