Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers
NCT03013881CI-TRIAL-00037907completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Biological | Trastuzumab | ALIAS |
| UB-921 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- UB-921 2 mg/kg (Main-study)
- description
- Intravenous infusion
- interventionNames
- Biological: UB-921
- type
- EXPERIMENTAL
- label
- UB-921 6 mg/kg (Main-study)
- description
- Intravenous infusion
- interventionNames
- Biological: UB-921
- type
- EXPERIMENTAL
- label
- UB-921 8 mg/kg (Main-study)
- description
- Intravenous infusion
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Total body weight ≧50 kg (110 lbs) * No clinically relevant abnormalities * To agree on using birth control barrier (eg. male condom) during the entire study period. * Signing the written informed consent form Exclusion Criteria: * Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational * A history of drug abuse or heavy drinking. * Blood donation over 250 mL within 90 days prior to the screening * Not in the condition to participate in this study considered by investigator(s)
References
Publications (0)
Data not yet available
No reference posted for this study.