Healthy VolunteersPhase 1NCT07765706
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants
A Phase 1 study testing INS1033 in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- INS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 22 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
001
Salt Lake City, Utah, 84124
About this study
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
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
- Being tested
- INS1033, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS1033Drug
Oral solution
PlaceboDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: INS1033; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
Measured: Part 1: Up to Day 7; Part 2: Up to Day 21
Secondary outcomes (1)
Plasma Concentration of INS1033
Measured: Pre-dose and post-dose at multiple timepoints (Part 1: Up to Day 7; Part 2: Up to Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start25 Aug 2026
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765706
- Sponsor's protocol ID
- INS1033-101
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07765706
- Acronym / sponsor ID
- INS1033-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: INS1033, Drug: PlaceboParticipants 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: PlaceboParticipants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS1033Oral solution | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD) |
| PlaceboOral solution | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD) |
Primary outcome
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
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Insmed Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INS1033 in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insmed Medical Information (18444467633, medicalinformation@insmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.