Healthy volunteersDrugPhase 1
What this study is
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.
What's being tested
- INS1033
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Oral solution
Study details
- Official title
- 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
- Sponsor
- Insmed Incorporated
- Conditions
- Healthy Volunteers
- Enrolling
- 116 people
- Starts
- 2026-08-25
- Est. completion
- 2027-03-22
- Design
- Double-blind, randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 open001
Salt Lake City, Utah, United States
Recruiting
Study team
Sponsor
Insmed Incorporated
Study ID INS1033-101
Study director
Study Director
Insmed Incorporated
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.