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
Overview
- Phase
- Phase 2
- Intervention
- AK0529
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Enrollment
- 160
- Locations
- 22
- Primary Endpoint
- Change of symptom score
- Last Updated
- 6 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
100mg AK0529 Arm
Patients randomised into this arm will be orally administered with 100mg AK0529 q.d. for five days.
Intervention: AK0529
200mg AK0529 Arm
Patients randomised into this arm will be orally administered with 200mg AK0529 q.d. for five days.
Intervention: AK0529
300mg AK0529 Arm
Patients randomised into this arm will be orally administered with 300mg AK0529 q.d. for five days.
Intervention: AK0529
Placebo Arm
Patients randomised into this arm will be orally administered with placebo q.d. for five days.
Intervention: Placebo
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Area under curve change of viral load(From Day 0 to Day 5)