drugset / Trial / NCT05116969
A Phase 1 Study of PTX-35 in Healthy Volunteers
RandomizedSequentialTriple-blindOther
Summary
A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers
Timeline
- Start
- 2021-11-24
- Primary completion
- 2022-11-29
- Completion
- 2022-11-29
Outcome
Outcome not reported
Stopped: “Sponsor withdrew submission to Human Research Ethics Committee as it evaluates the need for healthy volunteer data for development plan.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PTX-35 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | PTX-35 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | PTX-35 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | PTX-35 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | PTX-35 | Monoclonal antibody | 10 mg/kg | Intravenous |
Indications
No indication recorded.