Anti-RSV Study in Chinese Patients (ASCENT) (ASCENT)

November 25, 2019 updated by: Ark Biosciences Inc.

A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Orally Administered AK0529 in Adults With Respiratory Syncytial Virus Infection

This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered AK0529 in Chinese adults with RSV infection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study in Chinese adult outpatients with RSV infection. Approximately 160 eligible patients who have been recently diagnosed with RSV infection are planned to be enrolled into the study. Symptom scores of patients before and after treatment will be evaluated. Meanwhile, nasopharyngeal samples and blood samples will be collected for virological and pharmacokinetics evaluations. The evaluation of the safety and tolerability will include AE/SAE, vital signs, physical examination, laboratory examination and 12-lead ECGs. The total study duration for each patient will be 20 days.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, China, 101200
        • Recruiting
        • Beijing Pinggu Hospital
        • Contact:
      • Bengbu, China, 233004
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical college
        • Contact:
      • Nantong, China, 226001
        • Recruiting
        • NanTong First People's Hospital
        • Contact:
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
      • Shanghai, China, 201199
        • Recruiting
        • Central Hospital of Minhang District, Shanghai
        • Contact:
      • Shenzhen, China, 518001
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Xiangtan, China, 411100
        • Recruiting
        • Xiangtan Central Hospital
        • Contact:
      • Xinxiang, China, 453000
        • Recruiting
        • Xinxiang First People's Hospital
        • Contact:
      • Zunyi, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100015
        • Recruiting
        • Beijing Ditan Hospital
        • Contact:
      • Beijing, Beijing, China, 100029
        • Active, not recruiting
        • Beijing Anzhen Hospital
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • Active, not recruiting
        • Quanzhou First Hospital
    • Guangdong
      • Huizhou, Guangdong, China, 516001
        • Active, not recruiting
        • Huizhou Municipal Central Hospital
    • Hainan
      • Haikou, Hainan, China, 571199
        • Active, not recruiting
        • The Second Affiliated Hospital of Hainan Medical University
      • Sanya, Hainan, China, 572000
        • Recruiting
        • Sanya Central Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Active, not recruiting
        • The Second Hospital of Hebei Medical University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Active, not recruiting
        • Nanjing First Hospital
      • Taizhou, Jiangsu, China, 225300
        • Active, not recruiting
        • Jiangsu Taizhou People's Hospital
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Active, not recruiting
        • Qingdao Municipal Hospital
    • Sichuan
      • Deyang, Sichuan, China, 618000
        • Recruiting
        • People's Hospital Of DeYang City
        • Contact:
      • Suining, Sichuan, China, 629000
        • Recruiting
        • Suining Central Hopital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 - 75 years, inclusive.
  • Confirmed with RSV infection by rapid diagnostic testing.
  • New onset with documentation of the following symptoms within 72 hours prior to the start of screening: Respiratory symptoms: runny nose, stuffy nose, sneezing, sore throat, earache, cough, shortness of breath; Systemic symptoms: headache, fatigue / lethargy, fever, and muscle and / or joint ache. The patient must have four symptoms of above, and at least one of these must be respiratory symptom in nature.
  • Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

  • The patient has taken, is taking or needs to take any antiviral medication (e.g. ribavirin, Chinese medicine or herbs with effects of treating respiratory tract infection) within the 72 hours prior to screening.
  • Awareness of concomitant infections of respiratory viruses (eg, influenza A, B), bacterial or fungal infections, including systemic bacterial or fungal infections within 7 days prior to screening or during the screening period.
  • Patient frailty was evaluated as "Vulnerable" or worse according to the Clinical Frailty Scale with a score ≥ 4 at screening.
  • Awareness of having positive results on HBsAg or HCV antibody or HIV (HIV 1 or HIV 2).
  • Patient with active tuberculosis or is taking antituberculosis treatment.
  • Patient with severe gastrointestinal disease which could impact drug absorption, eg, vomiting, malabsorption syndrome, or short bowel syndrome caused by necrotizing enterocolitis.
  • Patient with any congenital heart disease, acute or chronic heart failure, ischemic heart disease, or congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation.
  • Patient with malignant tumor.
  • Patient has received or is waiting for bone marrow, stem cell or solid organ transplantation.
  • Patient with any immune-related disease to be treated within 12 months prior to screening.
  • Patient with clinical laboratoy test values of ≥ 2x the upper limit of normal (ULN) for alanine aminotransferase or aspartate aminotransferase, or >1x ULN for total bilirubin, or >1.5xULN for serum creatinine.
  • Patient with electrolyte disorders, eg, hypokalemia, hypocalcemia, or hypomagnesemia.
  • Patient with history of drug or alcohol abuse within 12 months prior to screening ("alcohol abuse" definition is >14 units per week: 1 unit = 10mL Alcohol, or 250mL of 4% beer, or 25 mL of 40% spirit, or 75 mL of 13% wine).
  • Patient has allergy or hypersensitivity to study medication or its compositions.
  • Female patient with positive pregnancy test result or is lactating.
  • Patient with fertility refusing to use medically effective contraceptives during the study or within three months of the end of study.
  • Patient participated in an investigational drug or device study within 60 days prior to screening.
  • Patient who in the opinion of the investigator, is deemed as ineligible for the study, including patients who are with active psychiatric disease, or are taking psychiatric medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 100mg AK0529 Arm
Patients randomised into this arm will be orally administered with 100mg AK0529 q.d. for five days.
Drug: AK0529
AK0529 is a novel compound being developed for the treatment of RSV infection. The capsule containing enteric coated AK0529 pellets will be orally administered to patients at one of a 100mg, 200mg or 300mg dose level.
Other Names:
  • Ziresovir
EXPERIMENTAL: 200mg AK0529 Arm
Patients randomised into this arm will be orally administered with 200mg AK0529 q.d. for five days.
Drug: AK0529
AK0529 is a novel compound being developed for the treatment of RSV infection. The capsule containing enteric coated AK0529 pellets will be orally administered to patients at one of a 100mg, 200mg or 300mg dose level.
Other Names:
  • Ziresovir
EXPERIMENTAL: 300mg AK0529 Arm
Patients randomised into this arm will be orally administered with 300mg AK0529 q.d. for five days.
Drug: AK0529
AK0529 is a novel compound being developed for the treatment of RSV infection. The capsule containing enteric coated AK0529 pellets will be orally administered to patients at one of a 100mg, 200mg or 300mg dose level.
Other Names:
  • Ziresovir
PLACEBO_COMPARATOR: Placebo Arm
Patients randomised into this arm will be orally administered with placebo q.d. for five days.
Drug: Placebo
The placebo is made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed of microcrystaline cellulose pellet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of symptom score
Time Frame: From Day 0 to Day 5
To evaluate the change of patient-reported symptom score in AK0529 arms compared with the change in placebo arm after treatment. The scale is Wang bronchiolitis score and the total score is reported with a range from 0 to 12. A decreasing value of total score represents clinical improvement. Subscales are not applicable in this symptom score.
From Day 0 to Day 5
Incidence of adverse events during the study
Time Frame: From Day -3 to Day 14
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
From Day -3 to Day 14
Subject withdrawals due to treatment-emergent adverse events
Time Frame: From Day -3 to Day 14
A treatment-emergent adverse event (TEAE) is an AE that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state.
From Day -3 to Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve change of viral load
Time Frame: From Day 0 to Day 5
The antiviral effects in adults with RSV infection are to be determined by measuring the RSV viral load area under the curve from baseline to last administration of study medication .
From Day 0 to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ark Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2019

Primary Completion (ANTICIPATED)

January 31, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK0529-2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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