INS1033 Safety and PK Test in Healthy Volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, interventional study evaluating single and multiple ascending doses of INS1033, compared with placebo, in healthy volunteers. The trial will monitor safety, tolerability, and pharmacokinetics to see how the drug is absorbed, distributed, and cleared. Participants will undergo screening and receive the study drug or placebo under close supervision, with key safety assessments like physical exams, vital signs, ECGs, and lab tests. The study is conducted at a single location in Salt Lake City, Utah, sponsored by Insmed Incorporated. Enrollment is limited to adults without significant medical conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• 001
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Insmed Medical Information
• Email: medicalinformation@insmed.com
• Phone: 18444467633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.