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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07765706

Enrollment

116

Registered

2026-08-14

Start date

2026-08-25

Completion date

2027-03-22

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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.

Interventions

DRUGINS1033

Oral solution

DRUGPlacebo

Oral solution

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

* 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/

Design outcomes

Primary

Measure	Time frame
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

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

Contacts

CONTACTInsmed Medical Information

medicalinformation@insmed.com18444467633

STUDY_DIRECTORStudy Director

Insmed Incorporated

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026