Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT07210320
Brief Summary:
This is an open-label, two-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray in healthy adults. For both 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) to help select the most appropriate dose/formulation to be used in Part 2 of the study in a larger number of participants (N=24).
Detailed Description:
This is an open-label, two-part, partially randomized single-dose crossover study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray in healthy adults.
Part 1 of the study will have four Treatment Periods testing two doses of IN-001 Sublingual Spray (Test Products) and two doses of approved epinephrine injection products (Reference Products). All participants will receive the same study drug and dose within each of the four Treatment Periods. There will be no randomization in Part 1 of the study. In Period 1, all participants will receive a single dose of EpiPen® (Epinephrine Injection) Auto-Injector 0.3 mg/0.3 mL of Mylan Specialty L.P., USA, once, in the morning after at least 10 hours of fasting. In Period 2, all participants will receive a single dose of Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle, once, in the morning after at least 10 hours of fasting. In Period 3, all participants will receive a single dose of L-dipivefrin (IN-001) 9.06 mg Sublingual Spray of Insignis Therapeutics, Inc., in the morning after at least 10 hours of fasting. In Period 4, all participants will receive a single dose of L-dipivefrin (IN-001) 13.59 mg Sublingual Spray of Insignis Therapeutics, Inc., in the morning after at least 10 hours of pasting. Following Periods 1 and 2, a washout period of at least 24 hours will be observed. Following Period 3, a washout period of 7 days will be observed before Period 4 dosing. Safety and tolerability will be assessed throughout the study.
Part 2 of this study is an open-label, three-period, randomized single-dose study. Participants will be randomized in a 1:1:1 allocation to determine the sequence in which they will be assigned to receive the study medications in Periods 1, 2, and 3. During each period, participants will receive a single dose of one of the three study products. By the end of the study, each participant will have received all three products through a crossover design. The following are the allocations to which participants will be randomized:
* The selected dose from Part 1 of either L-dipivefrin (IN-001) 9.06 mg or 13.59 mg Sublingual Spray by Insignis Therapeutics, Inc., once, in the morning after at least 10 hours of fasting.
* EpiPen® (Epinephrine Injection) Auto-Injector 0.3 mg/0.3 mL of Mylan Specialty L.P., USA, once, in the morning after at least 10 hours of fasting.
* Epinephrine 0.3 mg intramuscular injection, once, in the morning after at least 10 hours of fasting.
Following Periods 1 and 2, there will be a washout period of at least 24 hours that will be observed. Safety and tolerability will be assessed throughout the study.
Participants will exit the study after treatment Period 3 following completion of the 6-hour safety assessments and a 24-hour post-dose follow-up phone call. In the event that a participant completes the trial with a laboratory abnormality or unresolved adverse event (AE), the Investigator will attempt to provide follow-up until a satisfactory clinical resolution of the AE or laboratory result is achieved.
Up to 30 participants are planned to be enrolled in the trial overall. Up to six participants will be dosed Part 1 and up to 24 participants will be dosed in Part 2.
Study:
NCT07210320
Study Brief:
Protocol Section:
NCT07210320