Trials / Unknown
UnknownNCT03699202
Anti-RSV Study in Chinese Patients (ASCENT)
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2019-03-29
- Primary completion
- 2020-01-31
- Completion
- 2020-06-30
- First posted
- 2018-10-09
- Last updated
- 2019-11-27
Locations
22 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03699202. Inclusion in this directory is not an endorsement.