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

NCT07765706 — Phase 1, Recruiting, 116 participants, Insmed Incorporated

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Phase 1, Randomized, Double-blind, Placebo-controlled, 2-Part Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of INS1033 in Healthy Participants

Registry	NCT07765706
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: double, treatment
Enrollment	116 (Estimated)
Sponsor	Insmed Incorporated (Industry)
Conditions	Healthy Volunteers
Interventions	INS1033, Placebo (Drug)
Dates	start 2026-08-25, primary completion 2027-03-22 (estimated), completion 2027-03-22 (estimated), first posted 2026-08-14, last updated 2026-09-25
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Part 1: Single Ascending Dose (SAD)	Experimental	Drug: INS1033; Drug: Placebo	Participants 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)	Experimental	Drug: INS1033; Drug: Placebo	Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.

INS1033 (Drug): Oral solution
Placebo (Drug): Oral solution

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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:

* 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.

+Locations (1)

Facility	City	Country	Status
001	Salt Lake City, Utah	United States	Recruiting

+Investigators

Study Director, Study director, Insmed Incorporated

My Notes

Public

To Read Reading Read