Recruiting
Phase 1

INS1033

Sponsor:

Insmed Incorporated

Code:

NCT07765706

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

INS1033

Placebo

Study Details

Brief summary:

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

Conditions

Healthy Volunteers

Study ID

NCT07765706

Start date

Aug 25, 2026

Status verified date

Sep, 2026

Completion date

Mar 22, 2027

Anticipated

Primary completion date

Mar 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Single Ascending Dose (SAD)

Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.

experimental: Part 2: Multiple Ascending Dose (MAD)

Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.

Interventions

INS1033

Oral solution

Placebo

Oral solution

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Insmed Medical Information

18444467633medicalinformation@insmed.com

Locations

001

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Insmed Incorporated

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Insmed Incorporated on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.