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NCT03493191
A Single Dose Study of SHR0410 in Healthy Male Participants
Phase 1 trial testing 0.5μg/kg SHR0410 in Acute Pain in 48 participants. Completed in 14 July 2018.
29 June 2018
Quick facts
| Lead sponsor | Atridia Pty Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 15 April 2018 |
| Primary completion | 29 June 2018 |
| Estimated completion | 14 July 2018 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- 0.5μg/kg SHR0410 — full drug profile →
- 1μg/kg SHR0410 — full drug profile →
- 2μg/kg SHR0410 — full drug profile →
- 5μg/kg SHR0410 — full drug profile →
- 10μg/kg SHR0410
- 20μg/kg SHR0410 — full drug profile →
Conditions studied
- Acute Pain — all drugs for Acute Pain →
Sponsor
Atridia Pty Ltd. — full company profile →
Who can join
Adults 18 to 45, male only, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.
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 NCT03493191
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07348523 — Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Sp · NA · recruiting
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Other Atridia Pty Ltd. trials
Trials by the same sponsor.
- NCT07358377 — To Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects With HR-Positive/HER2-Negati · Phase 1 · not yet recruiting
- NCT07390747 — A Trial of SHR-2173 in Healthy Volunteers · Phase 1 · recruiting
- NCT07238647 — A Trial of HRS-5817 in Obese Participants · EARLY_PHASE1 · recruiting
- NCT07078695 — A Trial of SHR-1139 in Healthy Volunteers · Phase 1 · active not recruiting
- NCT07033455 — A Trial of HRS-1893 in Healthy Volunteers · EARLY_PHASE1 · 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 NCT03493191 (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 Atridia Pty Ltd.
- Last refreshed: 26 February 2019
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/NCT03493191.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing