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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Insmed Incorporated
Study ID
NCT07765706
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • INS1033 — DRUG
    Oral solution
  • Placebo — DRUG
    Oral solution

Study Details

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

Key Dates

First listed
Aug 14, 2026
Start date
Aug 25, 2026
Status verified
Sep 2026
Primary completion
Mar 22, 2027
Completion
Mar 22, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
001Salt Lake CityUtah84124-

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001· Salt Lake City, UT

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