Respiratory Syncytial Virus InfectionsPhase 2ASCENTNCT03699202
Anti-RSV Study in Chinese Patients (ASCENT)
A Phase 2 study testing AK0529 in people with Respiratory Syncytial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 22 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- AK0529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 22 sitesChina
- Study dates
- 28 Mar 2019to 4 Apr 2019
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
China-Japan Friendship Hospital
Beijing, 100029
Beijing Pinggu Hospital
Beijing, 101200
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
People's Hospital of Deyang City
Deyang, Sichuan, 618000
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 571199
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Nantong First People's Hospital
Nantong, 226001
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Quanzhou First Hospital
Quanzhou, Fujian, 362000
Sanya Central Hospital
Sanya, Hainan, 572000
Shanghai East Hospital
Shanghai, 200120
Central Hospital of Minhang District, Shanghai
Shanghai, 201199
Shenzhen People's Hospital
Shenzhen, 518001
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Suining Central Hopital
Suining, Sichuan, 629000
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Xiangtan Central Hospital
Xiangtan, 411100
Xinxiang First People's Hospital
Xinxiang, 453000
Affiliated Hospital of Zunyi Medical University
Zunyi, 563000
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- AK0529, Placebo
- Keywords
- RSV,AK0529,Chinese
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK0529Drug
Also called Ziresovir
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 100mg AK0529 Arm | Experimental | Patients randomised into this arm will be orally administered with 100mg AK0529 q.d. for five days. Receives: Drug: AK0529 |
| 200mg AK0529 Arm | Experimental | Patients randomised into this arm will be orally administered with 200mg AK0529 q.d. for five days. Receives: Drug: AK0529 |
| 300mg AK0529 Arm | Experimental | Patients randomised into this arm will be orally administered with 300mg AK0529 q.d. for five days. Receives: Drug: AK0529 |
| Placebo Arm | Placebo comparator | Patients randomised into this arm will be orally administered with placebo q.d. for five days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 0 to Day 5
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.
Measured: From Day -3 to Day 14
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.
Measured: From Day -3 to Day 14
Secondary outcomes (1)
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 .
Measured: From Day 0 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start28 Mar 2019
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Why it stopped: The study was terminated early due to COVID-19-related enrollment disruptions, not as a result of any product safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ark Clinical Trial, Study director, info@arkbiosciences.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699202
- Sponsor's protocol ID
- AK0529-2002
- Acronym
- ASCENT
- Status last verified
- Jun 2026
- First submitted
- 5 Oct 2018
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No