Trials / Unknown
UnknownNCT04277897
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
A Phase Ia Single-center,Randomized,Double-blind,Placebo-controled Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- Sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers
Detailed description
It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hepenofovir Fumarate Tablets Single Dose | Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD). |
| DRUG | Placebo | Placebo to match Hepenofovir Fumarate Tablets |
| DRUG | Hepenofovir Fumarate Tablets Dose4 | Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition. |
Timeline
- Start date
- 2020-03-15
- Primary completion
- 2020-06-30
- Completion
- 2020-09-30
- First posted
- 2020-02-20
- Last updated
- 2020-02-20
Source: ClinicalTrials.gov record NCT04277897. Inclusion in this directory is not an endorsement.