Last reviewed · How we verify
NCT04169256
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 in Healthy Volunteers
Phase 1 trial testing HYR-PB21 in Acute Postoperative Pain in 32 participants. Completed in 30 July 2020.
30 July 2020
Quick facts
| Lead sponsor | Fruithy Medical Pty Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 3 March 2020 |
| Primary completion | 30 July 2020 |
| Estimated completion | 30 July 2020 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- HYR-PB21 — full drug profile →
- Liposomal bupivacaine — full drug profile →
- Normal Saline
Conditions studied
- Acute Postoperative Pain — all drugs for Acute Postoperative Pain →
Sponsor
Fruithy Medical Pty Ltd — full company profile →
Who can join
Adults 18 to 50, any sex, with Acute Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is the first time into human study (FTIH) for HYR-PB21 for injection. The study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending and single subcutaneous dose of HYR-PB21 for injection in healthy adult volunteers.The results of this study are intended to be used to identify appropriate and well tolerated doses of HYR-PB21 for injection to be used in further studies. A comparison of PK/PD characteristics between HYR-PB21 for injection and EXPAREL will also be included in this study.
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 NCT04169256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Postoperative Pain
Currently open trials in the same condition.
- NCT07335250 — Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy · NA · recruiting
- NCT07452120 — DIPB vs. SIFIB for Postoperative Analgesia After Hip Surgery · NA · recruiting
- NCT06784882 — Continuous Versus Single Injection Adductor Canal Blocks for Outpatient Total Knee Arthroplasty · Phase 4 · recruiting
- NCT06661642 — Clinical Prediction of Post-surgical Pain · recruiting
- NCT06381401 — Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults · Phase 4 · recruiting
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 NCT04169256 (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 Fruithy Medical Pty Ltd
- Last refreshed: 4 February 2021
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/NCT04169256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing