drugset / Trial / NCT05531890
Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects
RandomizedCrossoverOpen-labelOther
Summary
A Randomized, Open-label, Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection - betamethasone and an Oral Solution of Betamethasone in Healthy Subjects. Four groups of subjects will receive 2 treatments each and randomized in 2-way crossover.
Timeline
- Start
- 2022-09-13
- Primary completion
- 2022-11-24
- Completion
- 2023-05-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GTX-102 | Antisense oligonucleotide | 0.025 mg/kg | Oral |
| Subject | GTX-102 | Antisense oligonucleotide | 0.05 mg/kg | Oral |
| Subject | GTX-102 | Antisense oligonucleotide | 0.1 mg/kg | Oral |