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 range18 Years – 45 Years
SexALL
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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)
✓. 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.
✕. 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.