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

NCT07765706 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: INS1033-101
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Plasma Concentration of INS1033

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

Study Arms (2)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.

Drug: INS1033; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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

INS1033 DRUG

Oral solution

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Placebo DRUG

Oral solution

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Officials

• Study Director

  Insmed Incorporated

  STUDY DIRECTOR

Central Study Contacts

Insmed Medical Information

CONTACT

18444467633; medicalinformation@insmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): March 22, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share