A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04603300|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : March 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: INT301 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind is controlled by IWRS|
|Official Title:||A Randomized Placebo-Controlled Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut.|
|Estimated Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||August 15, 2021|
Active Comparator: Active treatment
INT301 dosing as determined by cohort assignment
INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
Placebo Comparator: Placebo
Placebo as determined by cohort assignment
Fully functional toothpaste containing no immunotherapy agents
- To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study. [ Time Frame: Eight weeks ]Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions.
- To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301. [ Time Frame: Eight weeks ]Number of participants requiring treatment for systemic reactions related to experimental treatment or placebo; Number of adverse events requiring treatment for systemic reactions related to experimental treatment or placebo; Adherence to study treatment.
- To explore changes in peanut-specific IgG4 and IgE levels in participants (exploratory outcome). [ Time Frame: Eight weeks ]Change from baseline of peanut-specific IgG4 and IgE in study subjects (exploratory outcome)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603300
|Contact: Erick B Berglund, PhDfirstname.lastname@example.org|
|Contact: Michael Nelson, JDemail@example.com|
|United States, New Jersey|
|Belleville, New Jersey, United States, 07109|
|Contact: Jose Flores 201-320-7677 firstname.lastname@example.org|