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INS1033

Phase 1

Healthy Volunteers | Small molecule | Other |Insmed Incorporated|Last Updated: Aug 14, 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

Clinical trial landscape

INS1033 · 1 trial · 1 indication

Phase 1 1
NCT07765706A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy ParticipantsHealthy Volunteers
NOT YET_RECRUITING116 Analytics
PHASE1NOT YET_RECRUITING
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

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...

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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07765706NEW_TRIAL: changed
LOWAug 14, 2026NCT07765706NEW_TRIAL: changed

Frequently asked questions about INS1033

What is INS1033 used for?

INS1033 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development to assess its safety, tolerability, and pharmacokinetics. The drug is not approved for any condition and is being evaluated in a clinical trial setting.

Who makes INS1033?

INS1033 is being developed by Insmed Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol INSM. The company is conducting a Phase 1 study to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy participants.

What phase is INS1033 in?

INS1033 is in Phase 1 clinical development. It is an investigational drug being studied in a single Phase 1 trial that has not yet begun recruiting participants. The drug is not FDA approved and remains in early-stage clinical testing.

What clinical trials is INS1033 in?

INS1033 is being studied in one clinical trial, identified as NCT07765706. This Phase 1 study is designed to assess the safety, tolerability, and pharmacokinetics of INS1033 in healthy participants. The trial is not yet recruiting and has a planned enrollment of 116 participants.

Is INS1033 FDA approved?

INS1033 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing study is designed to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers, and the drug has not yet demonstrated efficacy or received regulatory approval.