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RecruitingNCT07765706Updated Nov 9, 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 2026-11-09.

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

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Sep 25, 2026Now RecruitingFirst site in United States+1 moreGo to Updates ↓
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

In context

Lead sponsor

Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.

Browse Insmed Incorporated studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy status as defined by the absence of evidence of any , 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 (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 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.
  • history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

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)

07

Study locations

1 of 1 sites recruiting
  • 001
    Salt Lake City, Utah 84124, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 14, 2026
StartActual
Aug 25, 2026
Primary completionEst.
Mar 22, 2027
CompletionEst.
Mar 22, 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
1 site added — first site in United States
Show site
  • 001 · Salt Lake City, United States
Sep 25, 2026
Show all 2 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: verification date
  2. Sep 25, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • 001 · Salt Lake City, United States
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Nov 9, 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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