PK/PD Study of IN-001 Sublingual Spray in Healthy Adults (NCT07210320) | Clinical Trial Compass
CompletedPhase 1
PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
United States32 participantsStarted 2025-10-24
Plain-language summary
This is an open-label, three-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray or drop in healthy adults. For all parts of the study, participants will undergo at least 10 hours of fasting prior to dosing. Part 1 of the study focuses on IN-001 dose/formulation exploration in a small number of participants (N=6); Part 2 of the study involving up to 12 participants will test a dose selected from Part 1 delivered as both a sublingual spray and a sublingual drop. In Part 3, one delivery method will be tested. Total number of participants is 30.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18 years of age and \< 45 years of age.
. Women of childbearing potential or men with childbearing potential partners must agree that the participant and/or their partner will use the following effective methods of birth control from screening visit until 14 days after the last dose of study drug:
. Abstinence
. Hormonal contraceptives for at least one month prior to Screening
. Double barrier (e.g., diaphragm with spermicide, condom with spermicide)
. Intrauterine device (IUD)
. Surgically sterile (e.g., bilateral tubal ligation, total or partial hysterectomy, or bilateral oophorectomy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. BMI \> 18.50 and \< 29.90 kg/m2 (using formula BMI = weight (kg)/height (m2).
Exclusion criteria
. Resident of a care facility, incarcerated individual, or individual in residential treatment facilities.
. Pregnant and/or breastfeeding.
. Females of childbearing potential should have a negative pregnancy test.
. Females must agree to refrain from breastfeeding from screening visit through 14 days after the last dose of study drug.
. Known history of Human Immunodeficiency Virus (HIV) 1 \& 2 and hepatitis B \& C virus.
. Clinically significant history of alcoholism within the last 12 months, per Investigator's discretion. Participants must
. Clinically significant history of addiction, abuse, and misuse of any drug, per the Investigator's discretion. Participants must
. Use of tobacco/nicotine containing products (e.g., chewing tobacco, smoking cigarettes, and/or electronic cigarettes) within the last 12 months. Participants must agree to abstain from using tobacco/nicotine containing products from the screening visit until the end of study.