Anti-RSV Study in Chinese Patients (ASCENT)

Respiratory Syncytial Virus Infections Clinical Trial

— ASCENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03699202
• Other study ID #: AK0529-2002
• Status: Recruiting
• Phase: Phase 2
• Start date: March 29, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2019
• Source: Ark Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing Pinggu Hospital	Beijing
China	China-Japan Friendship Hospital	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	People's Hospital of Deyang City	Deyang	Sichuan
China	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nantong First People's Hospital	Nantong
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Quanzhou First Hospital	Quanzhou	Fujian
China	Sanya Central Hospital	Sanya	Hainan
China	Central Hospital of Minhang District, Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai
China	Shenzhen People's Hospital	Shenzhen
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Suining Central Hopital	Suining	Sichuan
China	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu
China	Xiangtan Central Hospital	Xiangtan
China	Xinxiang First People's Hospital	Xinxiang
China	Affiliated Hospital of Zunyi Medical University	Zunyi

Sponsors (1)

Lead Sponsor	Collaborator
Ark Biosciences Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of symptom score	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
Primary	Incidence of adverse events during the study	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
Primary	Subject withdrawals due to treatment-emergent adverse events	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	Area under curve change of viral load	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