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INS1033

Phase 1

Undisclosed | Small molecule | Other |Insmed Incorporated|Trials Updated: Sep 25, 2026

INS1033 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

INS1033 clinical trials

INS1033 · 1 trial · 1 indication

Phase 1 1
NCT07765706A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy ParticipantsHealthy Volunteers
RECRUITING116 Analytics
PHASE1RECRUITING
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
Part 1: Up to Day 7; Part 2: Up to Day 21

Secondary Endpoints

Plasma Concentration of INS1033
Pre-dose and post-dose at multiple timepoints (Part 1: Up to Day 7; Part 2: Up to Day 21)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Single Ascending Dose (SAD)EXPERIMENTALParticipants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.
Part 2: Multiple Ascending Dose (MAD)EXPERIMENTALParticipants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.

Interventions

NameTypeDescription
INS1033DRUGOral solution
PlaceboDRUGOral solution
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 25, 2026NCT07765706Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 25, 2026NCT07765706Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07765706NEW_TRIAL: changed
LOWAug 14, 2026NCT07765706NEW_TRIAL: changed

Frequently asked questions about INS1033

What is INS1033?

INS1033 is an investigational small molecule being developed by Insmed Incorporated. It is in Phase 1 clinical development, with a single active trial currently recruiting healthy adult volunteers in the United States. No therapeutic indication for INS1033 has been disclosed.

Who is developing INS1033?

INS1033 is being developed by Insmed Incorporated, which trades on the Nasdaq under the ticker INSM. Insmed is the sponsor of the Phase 1 study evaluating the compound in healthy participants.

What phase is INS1033 in?

INS1033 is in Phase 1 clinical development. It has one active, recruiting trial and no completed trials. Because it is investigational, INS1033 has not been approved by the FDA for any indication.

What clinical trials is INS1033 in?

INS1033 is being studied in one Phase 1 trial, NCT07765706, titled a study to assess the safety, tolerability and pharmacokinetics of INS1033 in healthy participants. The trial is recruiting, is randomized, double blind, and controlled, and plans to enroll 116 healthy volunteers aged 18 and older in the United States.

Is INS1033 tested in healthy volunteers?

Yes. The Phase 1 trial of INS1033, NCT07765706, enrolls healthy adult volunteers rather than patients with a specific disease. The study is designed to assess safety, tolerability, and pharmacokinetics, and it plans to enroll 116 participants across sites in the United States.