A Phase 1 interventional study of INS1033 and Placebo in Healthy Volunteers, sponsored by Insmed Incorporated. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Insmed Incorporated · Phase 1, Interventional, and Treatment
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.
Drug: INS1033 · Drug: Placebo
Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.
Drug: INS1033 · Drug: Placebo
Oral solution
Oral solution
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
Plasma Concentration of INS1033
Time frame: Pre-dose and post-dose at multiple timepoints (Part 1: Up to Day 7; Part 2: Up to Day 21)
Plan to share: No
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Insmed Incorporated