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NCT05711797: ZX-7101A-203
Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects
Phase 1 trial testing ZX-7101A 80mg in Influenza, Human in 16 participants. Completed in 9 August 2024.
6 February 2024
Quick facts
| Lead sponsor | Nanjing Zenshine Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 12 April 2023 |
| Primary completion | 6 February 2024 |
| Estimated completion | 9 August 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- ZX-7101A 80mg — full drug profile →
Conditions studied
- Influenza, Human — all drugs for Influenza, Human →
Sponsor
Nanjing Zenshine Pharmaceuticals — full company profile →
Who can join
Adults 18 to 70, any sex, with Influenza, Human. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects. The main questions it aims to answer are: * Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex. * To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05711797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ZX-7101A 80mg
Trials testing the same drug.
- NCT05720091 — Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China · Phase 1 · completed
Other recruiting trials for Influenza, Human
Currently open trials in the same condition.
- NCT07204964 — A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above · Phase 2 · active not recruiting
- NCT07121192 — A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older · Phase 2 · active not recruiting
- NCT05921448 — Vaccine Pandemic Preparedness Through Airway Immunology Characterization · EARLY_PHASE1 · active not recruiting
- NCT06573008 — Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications · Phase 3 · recruiting
- NCT06622590 — Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine · Phase 1 · active not recruiting
Other Nanjing Zenshine Pharmaceuticals trials
Trials by the same sponsor.
- NCT07310134 — Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Adva · Phase 1 · recruiting
- NCT07095257 — Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years · Phase 3 · completed
- NCT06841926 — Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males · Phase 1 · completed
- NCT06669351 — Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years With Influenza · Phase 3 · terminated
- NCT06099873 — Study to Assess the Safety and Efficacy of ZX-7101A in Adolescents With Influenza · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05711797 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanjing Zenshine Pharmaceuticals
- Last refreshed: 5 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05711797.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing