A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants
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
- Healthy Volunteers
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Insmed Incorporated
- Enrolment target
- 116
- Started
- 25 August 2026
- Main results due
- 22 March 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 50 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(1)
001
Salt Lake City, Utah, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07765706. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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