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A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants

RecruitingPhase 1Healthy volunteers welcome

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

Who can join

Ages 18 to 50 · All sexes · Healthy volunteers welcome

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.

About the study

The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.

What is being tested

Sponsor: Insmed Incorporated · Participants: 116 · Started: Aug 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07765706

Locations in the U.S.

Utah001, Salt Lake City

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.