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NCT05962645
Phase 1 Study Into Pharmacokinetics and Food Effect of Vapendavir in Healthy Participants and Participants With COPD
Phase 1 trial testing Vapendavir in COPD in 21 participants. Completed in 2 May 2024.
12 December 2023
Quick facts
| Lead sponsor | Altesa Biosciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 19 May 2023 |
| Primary completion | 12 December 2023 |
| Estimated completion | 2 May 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vapendavir — full drug profile →
Conditions studied
- COPD — all drugs for COPD →
- Respiratory Disease — all drugs for Respiratory Disease →
- Lower Respiratory Disease — all drugs for Lower Respiratory Disease →
- Pulmonary Disease — all drugs for Pulmonary Disease →
Sponsor
Altesa Biosciences, Inc.
Who can join
Adults 18 to 55, any sex, with COPD or Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vapendavir (VPV) is potent virostatic antiviral agent active against all known enterovirus species. VPV binds to the viral capsid, thereby inhibiting viral attachment to the target cell and, independently, preventing release of viral RNA (ribonucleic acid) into the cell. Alt VPV-101 is meant to investigate vapendavir in patients with chronic obstructive pulmonary disease (COPD) who develop a rhinoviral infection. This is a Phase 1, open-label, unblinded study. The primary objective of this study is to characterize single and multiple dose (plus a loading dose) plasma PK profiles of VPV in healthy participants (Group A) and participants with COPD (Group B). Group A is an open-label, 2-sequence, and up to a 3-period, cross-over study to assess the single-dose PK parameters and safety of VPV. Healthy participants may opt to participate in only the first 2 periods, all 3 periods or BID dosing, but it is preferred that participants complete all 3 periods. Group B is an open-label, multi-dose investigation of VPV PK parameters and safety in participants with COPD. Post-dose, follow up will continue for a minimum of 14 days and a maximum of 30 days, depending on which Group the participant is in and which periods said participant completes. There is a target for up to 24 adult participants comprised of healthy participants and participants with COPD.
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 NCT05962645
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vapendavir
Trials testing the same drug.
- NCT06834295 — A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir · Phase 1, PHASE2 · completed
- NCT06149494 — RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection · Phase 2 · completed
Other recruiting trials for COPD
Currently open trials in the same condition.
- NCT07344649 — Turkish Validation of the Nijmegen Questionnaire in COPD · recruiting
- NCT07524023 — Emotional-distress-based Integrated Care Programme in Patients With Stable COPD · NA · recruiting
- NCT07460154 — Structured Review: To Optimise Management and Prevent Harm in COPD · NA · recruiting
- NCT07462221 — Effect of Telenursing on Oral Health · NA · recruiting
- NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting
Other Altesa Biosciences, Inc. trials
Trials by the same sponsor.
- NCT06834295 — A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir · Phase 1, PHASE2 · completed
- NCT06149494 — RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection · Phase 2 · 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 NCT05962645 (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 Altesa Biosciences, Inc.
- Last refreshed: 30 July 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/NCT05962645.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing