A Phase 1, Randomized, Double-blind, Placebo-controlled, 2-Part Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of INS1033 in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Insmed Incorporated
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
Study Overview
Brief Summary
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis.
- •All values for hematology, coagulation and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator. Clinical laboratory tests may be repeated once.
Exclusion Criteria
- •Use of any investigational drug or device within 30 days of the first dose of INS1033, or within 5 half-lives, whichever is longer.
- •Any disease e.g. which, in the opinion of the Investigator, poses an unacceptable risk to the participants.
- •Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Part 1: Single Ascending Dose (SAD)
Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.
Intervention: INS1033 (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.
Intervention: INS1033 (Drug)
Part 1: Single Ascending Dose (SAD)
Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.
Intervention: Placebo (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
Time Frame: Part 1: Up to Day 7; Part 2: Up to Day 21
Secondary Outcomes
- Plasma Concentration of INS1033(Pre-dose and post-dose at multiple timepoints (Part 1: Up to Day 7; Part 2: Up to Day 21))