Phase 1 Clinical Trial
Official title:
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects.
This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.
GBS-101 is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study to evaluate the safety, tolerability and PK of GV101 in healthy subjects. 8 healthy subjects wills be enrolled cohorts 5 - 7 cohorts of the study. Cohorts 1-4 were previously completed with a tablet form of the study drug at 50 mg, 100 mg, 200 mg, and 400 mg. Planned cohorts 5 - 7 will be dosed 400 mg (liquid), 800 mg (liquid), 1600 mg (liquid) or matched placebo.. Participants will be randomized in a 3:1 ratio, 1:1 for 2 sentinel subjects and 5: 1 GV101 drug to matching placebo thereafter. Subjects in each cohort will receive a single oral dose of GV101 or matching placebo under fasting conditions. A staggered schedule will be used for each dose level, where 2 sentinel subjects (1 active and 1 placebo) will be dosed first, with the remaining 6 subjects (5 active and 1 placebo) dosed at least 24 hours after the sentinel subjects. This study of GV101 will provide safety, tolerability, and plasma pharmacokinetic data in healthy individuals. The PK component will characterize the PK of GV101 to inform dosing and may help to correlate exposures treatment-related AEs. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02010944 -
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
|
Phase 1 | |
| Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
| Completed |
NCT03273192 -
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03883620 -
Safety Study of Dengushield in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01091532 -
A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.
|
Phase 1 | |
| Completed |
NCT02634489 -
EC905 Pharmacokinetic Profile Study
|
Phase 1 | |
| Completed |
NCT04327089 -
Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects
|
Phase 1 | |
| Completed |
NCT03647670 -
A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03488719 -
A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate
|
Phase 1 | |
| Completed |
NCT03983876 -
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
|
Phase 1 | |
| Completed |
NCT03273088 -
Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT03740217 -
Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets
|
Phase 1 | |
| Recruiting |
NCT06214858 -
The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04014257 -
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
|
Phase 1 |