Trial · NCT03616223
FX-322 in Sensorineural Hearing Loss
NCT03616223, Phase 1, Phase 2, Completed, Frequency Therapeutics; results first posted 2022-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FX-322 in Sensorineural Hearing Loss. Trials, record NCT03616223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03616223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FX-322 in Sensorineural Hearing Loss
- NCT number
- NCT03616223
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Frequency Therapeutics
- Conditions
- Sensorineural Hearing Loss
- Interventions
- FX-322, Placebo
- First posted
- 2018-08-06
- Last updated
- 2022-11-14
- Results first posted
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | Baseline through Day 90 | Treatment-emergent adverse events (TEAE) were defined as any untoward medical occurrence in a subject administered study drug that does not necessarily have a causal relationship with the treatment and were collected from the time of first dose through end of study (day 90). In particular, audiometric and otoscopic TEAEs were recorded per the American Speech-Language-Hearing Association (ASHA) guidelines. |
| Secondary | Cmax | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Maximum concentration (Cmax) of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data |
| Secondary | Tmax | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Time to reach maximum concentration of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data |
| Secondary | AUClast | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Area under the concentration-time curve of FX-322 (Laduviglusib and Sodium Valproate) from time zero to the time of the last quantifiable concentration, calculated using the linear trapezoidal rule |
| Secondary | t1/2 | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | The observed terminal elimination half-life of FX-322 (Laduviglusib and Sodium Valproate) |
| Secondary | CL/F | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Apparent total body clearance after extravascular administration of FX-322 (Laduviglusib and Sodium Valproate) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | Baseline through Day 90 | Safety Analysis Set = All subjects exposed to study drug and analyzed according to the actual treatment received regardless of the randomized treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cmax | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Pharmacokinetic Analysis Set = All subjects in the Safety Analysis Set with measurable plasma concentrations | ng/mL | MEAN |
| SECONDARY | Tmax | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Pharmacokinetic Analysis Set = All subjects in the Safety Analysis Set with measurable plasma concentrations | hr | MEAN |
| SECONDARY | AUClast | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Pharmacokinetic Analysis Set = All subjects in the Safety Analysis Set with measurable plasma concentrations | ng*hr/mL | MEAN |
| SECONDARY | t1/2 | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Pharmacokinetic Analysis Set = Subjects in the Safety Analysis Set with plasma concentrations above the limit of quantification. Concentration-time data below the limit of quantification (BLQ) were treated as zero. The values of 4 of 7 subjects in the low dose group and 2 of 8 subjects in the high dose group were BLQ and were thus excluded from the PAS for t1/2 as those values could not be calculated. The number analyzed for each data point below reflects quantifiable levels within in each group | hr | MEAN |
| SECONDARY | CL/F | Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose | Pharmacokinetic Analysis Set = Subjects in the Safety Analysis Set with plasma concentrations above the limit of quantification. Concentration-time data below the limit of quantification (BLQ) were treated as zero. The values of 4 of 7 subjects in the low dose group and 2 of 8 subjects in the high dose group were BLQ and were thus excluded from the PAS for CL/F as those values could not be calculated. The number analyzed for each data point below reflects quantifiable levels within in each group | L/hr | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | Placebo-Low Dose | 2 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | Placebo-High Dose | 3 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | Pooled Placebo | 5 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | FX-322 Low Dose | 6 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) | FX-322 High Dose | 7 | Participants | ||
| Cmax | FX-322 Low Dose | Cmax of laduviglusib | 0.62 | Standard Deviation 0.191 | ng/mL |
| Cmax | FX-322 High Dose | Cmax of laduviglusib | 0.967 | Standard Deviation 0.361 | ng/mL |
| Cmax | FX-322 Low Dose | Cmax of sodium valproate | 345 | Standard Deviation 94.9 | ng/mL |
| Cmax | FX-322 High Dose | Cmax of sodium valproate | 767 | Standard Deviation 309 | ng/mL |
| Tmax | FX-322 Low Dose | Tmax of laduviglusib | 0.95 | Standard Deviation 0.206 | hr |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo-Low Dose | 4 | |
| Overall Study | STARTED | Placebo-High Dose | 4 | |
| Overall Study | STARTED | FX-322 Low Dose | 7 | |
| Overall Study | STARTED | FX-322 High Dose | 8 | |
| Overall Study | COMPLETED | Placebo-Low Dose | 4 | |
| Overall Study | COMPLETED | Placebo-High Dose | 4 | |
| Overall Study | COMPLETED | FX-322 Low Dose | 7 | |
| Overall Study | COMPLETED | FX-322 High Dose | 8 | |
| Overall Study | NOT COMPLETED | Placebo-Low Dose | 0 | |
| Overall Study | NOT COMPLETED | Placebo-High Dose | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear Discomfort | Ear and labyrinth disorders | Placebo-Low Dose | 1 | 4 | |
| other | Ear Discomfort | Ear and labyrinth disorders | Placebo-High Dose | 1 | 4 | |
| other | Ear Discomfort | Ear and labyrinth disorders | Pooled Placebo | 2 | 8 | |
| other | Ear Discomfort | Ear and labyrinth disorders | FX-322 Low Dose | 5 | 7 | |
| other | Ear Discomfort | Ear and labyrinth disorders | FX-322 High Dose | 4 | 8 | |
| other | Ear Pain | Ear and labyrinth disorders | Placebo-Low Dose | 1 | 4 | |
| other | Ear Pain | Ear and labyrinth disorders | Placebo-High Dose | 2 | 4 | |
| other | Ear Pain | Ear and labyrinth disorders | Pooled Placebo | 3 | 8 | |
| other | Ear Pain | Ear and labyrinth disorders | FX-322 Low Dose | 1 | 7 | |
| other | Ear Pain | Ear and labyrinth disorders | FX-322 High Dose | 3 | 8 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-Low Dose | 0 | 4 |
| Total, all-cause mortality | Placebo-High Dose | 0 | 4 |
| Total, all-cause mortality | Pooled Placebo | 0 | 8 |
| Total, all-cause mortality | FX-322 Low Dose | 0 | 7 |
| Total, all-cause mortality | FX-322 High Dose | 0 | 8 |
| Total, other adverse events | Placebo-Low Dose | 2 | 4 |
| Total, other adverse events | Placebo-High Dose | 3 | 4 |
| Total, other adverse events | Pooled Placebo | 5 | 8 |
| Total, other adverse events | FX-322 Low Dose | 6 | 7 |
| Total, other adverse events | FX-322 High Dose | 7 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03616223
GET https://conductscience.org/api/trials/v1/NCT03616223/results?page=2