Single Ascending Dose Study to Evaluate the Safety and Tolerability of LPT99 Administered to Healthy Adult Subjects
- Conditions
- Prevention of Hearing lossEar - Other ear disorders
- Registration Number
- ACTRN12618001461280
- Lead Sponsor
- Spiral Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
1. Male or female subject, age 18 to 65 years (inclusive) at Screening
2. Provides written informed consent prior to participation in any study procedure
3. Normal hearing, defined as is greater than or equal to 20 dB from 250 Hz to 8 kHz bilaterally
4. Normal tympanogram
5. No known allergies to lidocaine or prilocaine local anesthesia, to EMLA® (lidocaine
2.5% and prilocaine 2.5%) cream, or to phenol
6. Female subjects of childbearing potential, must not be pregnant, lactating, or planning
a pregnancy, must have a negative pregnancy test at screening and at Day -1, and
must use a medically acceptable method of contraception [e.g., intrauterine device
(IUD), intrauterine system (IUS), or hormonal contraception (oral, implant, or
injectable) begun >30 days prior to screening]. Acceptable contraceptive options may
also include abstinence (if this is the preferred lifestyle for the participant), physical
relationship with a same-sex partner or a partner who has had a vasectomy at least 6
months prior to Screening. Subjects must agree to adhere to contraceptive measures
from screening through 30 days after study drug administration.
7. Male subjects must be surgically sterile (vasectomy at least 6 months prior to
screening) or practice acceptable methods of contraception, and must agree to abstain
from sperm donation, from study drug administration through 90 days after
administration of study drug. Male subjects must agree to use a condom to protect
male and female partners from exposure to study drug. Male subjects with female
partners of childbearing potential, must also agree to partner use of hormonal
contraception (oral, implant, or injection), an IUD, or an IUS. Complete abstinence
from sexual intercourse, if this is the preferred lifestyle for the participant, is an
acceptable contraceptive option.
1. Bleeding disorder that could affect the TT study drug administration
2. Use of anticoagulant medication within 30 days prior to screening.
3. History of surgery to the inner ear
4. History of chronic tinnitus or Meniere's disease
5. History of radiation therapy to the head or neck
6. History of chronic middle ear infection, endolymphatic sac surgery
7. History of known hypersensitivity to any components of the study drug or formulation
8. Positive alcohol or urine drug test at Screening or on Study Day -1
9. Positive pregnancy test at Screening or on study Day -1
10. Acute illness or history of illness, that, in the opinion of the Investigator, could pose a
threat to or harm the subject, or obscure interpretation of laboratory test results or
study data
11. Acute respiratory infection, acute nasopharyngitis, sinusitis, chronic cough, or
symptoms of allergic rhinitis
12. Any clinically significant abnormalities on Screening or Day -1 laboratories, as
determined by the Investigator
13. Abnormality of tympanic membrane (perforation, retraction, history of any ear
surgery, effusion or other middle ear pathology) that would preclude TT
administration
14. Received study drug or placebo in another clinical study within the 30 days prior to
study drug administration
15. Deemed unsuitable for study participation by the Investigator, based on the
Investigator's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method