Trial Outcomes & Findings for Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss (NCT NCT04462198)
NCT ID: NCT04462198
Last Updated: 2025-04-01
Results Overview
Number of participants with TEAEs
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From baseline to 3 months follow up
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
PIPE-505
PIPE-505: Intratympanic injection
|
Placebo
Diluent alone: Intratympanic injection
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
7
|
|
Overall Study
COMPLETED
|
21
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Baseline characteristics by cohort
| Measure |
PIPE-505
n=21 Participants
PIPE-505: Intratympanic injection
|
Placebo
n=7 Participants
Diluent alone: Intratympanic injection
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 11.22 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
7 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 3 months follow upNumber of participants with TEAEs
Outcome measures
| Measure |
PIPE-505
n=21 Participants
PIPE-505: Intratympanic injection
|
Placebo
n=7 Participants
Diluent alone: Intratympanic injection
|
|---|---|---|
|
Safety: Treatment-Emergent Adverse Events (TEAE)
|
13 Participants
|
5 Participants
|
Adverse Events
PIPE-505
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PIPE-505
n=21 participants at risk
PIPE-505: Intratympanic injection
|
Placebo
n=7 participants at risk
Diluent alone: Intratympanic injection
|
|---|---|---|
|
Ear and labyrinth disorders
Deafness unilateral
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Ear and labyrinth disorders
Ear congestion
|
9.5%
2/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Ear and labyrinth disorders
Ear discomfort
|
23.8%
5/21 • 90 days
|
28.6%
2/7 • 90 days
|
|
Ear and labyrinth disorders
Ear pain
|
14.3%
3/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Ear and labyrinth disorders
Ear pruritus
|
9.5%
2/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Ear and labyrinth disorders
Hypoacusis
|
9.5%
2/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Ear and labyrinth disorders
Inner ear disorder
|
23.8%
5/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Ear and labyrinth disorders
Tympanic membrane hyperemia
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
General disorders
Chills
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
General disorders
Pain
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Infections and infestations
Gastroenteritis
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Infections and infestations
Otitis media
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Infections and infestations
Tooth infection
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Investigations
Blood creatine phosphokinase increased
|
9.5%
2/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Investigations
Blood glucose increased
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Investigations
Lymphocyte count decreased
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Investigations
Neutrophil count increased
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Nervous system disorders
Dizziness
|
19.0%
4/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • 90 days
|
14.3%
1/7 • 90 days
|
|
Renal and urinary disorders
Renal cyst
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
1/21 • 90 days
|
0.00%
0/7 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place