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RecruitingAccepts healthy volunteersPhase 1

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

Insmed Incorporated · NCT07765706

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–50 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
116
US sites recruiting
1
Study start
August 25, 2026
Record last updated
September 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: INS1033; Placebo

Conditions: Healthy Volunteers

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Insmed Medical Information · 18444467633 · medicalinformation@insmed.com