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NCT06233916
Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
Phase 1 trial testing [14C] D-1553 in Mass Balance Study in 8 participants. Completed in 10 January 2024.
3 January 2024
Quick facts
| Lead sponsor | InventisBio Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 8 |
| Start date | 8 December 2023 |
| Primary completion | 3 January 2024 |
| Estimated completion | 10 January 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- [14C] D-1553 — full drug profile →
Conditions studied
- Mass Balance Study — all drugs for Mass Balance Study →
Sponsor
InventisBio Co., Ltd — full company profile →
Who can join
Adults 19 to 55, male only, with Mass Balance Study. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
* To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of \[14C\] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans; * To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways; * To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.
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 NCT06233916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other InventisBio Co., Ltd trials
Trials by the same sponsor.
- NCT07411742 — Mass Balance Study of [14C] D-2570 · Phase 1 · not yet recruiting
- NCT07311200 — A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE) · Phase 2 · not yet recruiting
- NCT07326813 — A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis. · Phase 3 · not yet recruiting
- NCT07315061 — A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis · Phase 2 · recruiting
- NCT07130604 — Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis · Phase 3 · 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 NCT06233916 (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 InventisBio Co., Ltd
- Last refreshed: 1 February 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/NCT06233916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing