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RecruitingNCT07765706Updated Sep 25, 2026

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

A Phase 1 interventional study of INS1033 and Placebo in Healthy Volunteers, sponsored by Insmed Incorporated. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Insmed Incorporated · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
116 participants (estimated)

Study 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.

    Drug: INS1033 · Drug: Placebo

  • 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.

    Drug: INS1033 · Drug: Placebo

Interventions

  • DrugINS1033

    Oral solution

  • DrugPlacebo

    Oral solution

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Plasma Concentration of INS1033

    Time frame: Pre-dose and post-dose at multiple timepoints (Part 1: Up to Day 7; Part 2: Up to Day 21)

06

Study locations

1 of 1 sites recruiting
  • 001
    Salt Lake City, Utah 84124, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07765706
Lead sponsor
Insmed Incorporated
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 25, 2026
Primary completion
Mar 22, 2027 (estimated)
Completion
Mar 22, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Insmed Medical Information
Contact
medicalinformation@insmed.com
18444467633
Study Director
study director · Insmed Incorporated

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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