Idiopathic Pulmonary FibrosisPhase 1NCT07225296
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
A Phase 1 study testing GNS-3545 in people with Idiopathic Pulmonary Fibrosis, run by Genosco Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one cohort in Part 1. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- GNS-3545
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age
- Male subjects must follow protocol specified contraception guidance
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit and body weight of ≥ 50 kg
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee
- No ECG findings of clinical significance as judged by the PI or qualified designee
- Understands the study procedures in the ICF and be willing and able to comply with the protocol
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems
- History or presence of clinically significant medical or psychiatric conditions
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Surgical procedure or Administration of a live vaccination within 30 days prior to the first dose of the study drug
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- History or presence of hepatic impairment
Show all 19Show fewer
- History or presence of significant cardiovascular conditions or risk factors
- Subjects with a higher risk of adverse events in the setting of blood pressure decreases
- History or presence of hypersensitivity to compounds related to the study drug excipients
- Allergy to non-latex band aids, adhesive dressing, or medical tape
- Female subjects of childbearing potential or Female subject with a positive pregnancy test or who is lactating
- Positive urine drug or serum alcohol results
- Positive results at the screening visit for HIV, HBsAg, or HCV, or a clinically significant history of infection within 3 months prior to screening
- Inability or unwillingness to avoid use of medications, supplements, or substances that may affect CYP enzymes, drug transporters, blood pressure, or QT/QTc interval within the specified washout periods prior to dosing
- Has been on a diet incompatible with the on-study diet, or unable to swallow multiple tablets by mouth
- Has donated or lost more than 500 mL of blood within 56 days prior to the first dosing, or Plasma donation within 7 days prior to the first dosing
- Subjects with dietary restrictions that would prevent subjects from consuming a high-fat/high-calorie meal
- Participation in another clinical study within 30 days or 5 half-lives of the product prior to the first dosing
- Any reason determined by the PI or designee, in their opinion, that would prevent the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-effect Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GNS-3545 in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one cohort in Part 1.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- GNS-3545, GNS-3545 Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNS-3545Drug
GNS-3545 will be administered as oral tablets at assigned dose levels to six of the eight participants within each cohort in Part 1 (SAD) and Part 2 (MAD).
In Part 1, participants will receive a single dose on one occasion (Day 1). In Part 2, participants will receive daily dosing for 14 consecutive days.
GNS-3545 PlaceboDrug
The placebo will be administered as oral tablets identical in appearance to the GNS-3545 tablets to two of the eight participants within each cohort in Part 1 (SAD) and Part 2 (MAD).
In Part 1, participants will receive a single placebo dose on one occasion (Day 1).
In Part 2, participants will receive once-daily placebo doses for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| GNS-3545 | Experimental | Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo.
Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo. Receives: Drug: GNS-3545 |
| GNS-3545 Placebo | Placebo comparator | Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo.
Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo. Receives: Drug: GNS-3545 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
Number and severity of treatment-emergent adverse events (TEAEs) following single and multiple doses of GNS-3545 and placebo
Measured: Collection of TEAEs occurs from the point of first dose administration (Day 1 in each part) through to study completion (up to 8 days from the first dosing for Part 1 & up to 8 days from the last dosing for Part 2).
Secondary outcomes (6)
Area under the time-concentration curve (AUC) from zero (pre-dose) to 24 hours (h) post-dose sample [0-24 h])
Pharmacokinetic profile of GNS-3545 and its active metabolite in plasma
Measured: Up to 4 days from the last dosing for Part 1 (SAD), Up to 4 days from the last dosing for Food Effect Cohort (Part 1), Up to 17 days from the last dosing for Part 2 (MAD)
Area under the time-concentration curve (AUC) from zero (pre-dose) to the time of the last measurable concentration (t) [0-t])
Pharmacokinetic profile of GNS-3545 and its active metabolite in plasma
Measured: Up to 4 days from the last dosing for Part 1 (SAD), Up to 4 days from the last dosing for Food Effect Cohort (Part 1), Up to 17 days from the last dosing for Part 2 (MAD)
Maximum observed concentration (Cmax) after a single dose and at steady state (Cmax,ss)
Pharmacokinetic profile of GNS-3545 and its active metabolite in plasma
Measured: Cmax for up to 4 days from the last dosing for Part 1 (SAD), Cmax for up to 4 days from the last dosing for Food Effect Cohort (Part 1), Cmax & Cmax,ss up to 17 days from the last dosing for Part 2 (MAD)
Time to reach maximum observed concentration (Tmax) after a single dose and at steady state (Tmax,ss)
Pharmacokinetic profile of GNS-3545 and its active metabolite in plasma
Measured: Tmax up to 4 days from the last dosing for Part 1 (SAD), Tmax for up to 4 days from the last dosing for Food Effect Cohort (Part 1), Tmax & Tmax,ss up to 17 days from the last dosing for Part 2 (MAD)
Cumulative amount excreted in urine over the collection interval (CumAe) after a single dose and at steady state (CumAe,ss)
Pharmacokinetic profile of GNS-3545 and its active metabolite in urine
Measured: CumAe for up to 4 days from the last dosing for Part 1 (SAD), CumAe,ss up to 17 days from the last dosing for Part 2 (MAD)
Lag time before the first measurable concentration (Tlag)
Pharmacokinetic profile of GNS-3545 and its active metabolite in plasma
Measured: Up to 4 days from the last dosing for Food Effect Cohort Only (Part 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start12 Nov 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Model description
- This is a first-in-human, single ascending dose (SAD, Part 1) and multiple ascending dose (MAD, Part 2) study of orally administered GNS-3545 in healthy adults. Each cohort will include 8 participants (6 active, 2 placebo). In Part 1, a single oral dose will be administered under fasting conditions. In Part 2, once-daily dosing will be administered for 14 consecutive days under fasting conditions. Sequential cohorts will receive increasing doses, with dose escalation decisions based on safety and tolerability reviews by the Safety Review Committee (SRC). Six (6) cohorts (S1 to S6) are planned for evaluation in Part 1 (SAD), and Three (3) cohorts (M1 to M3) are planned for evaluation in Part 2 (MAD).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genosco Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225296
- Sponsor's protocol ID
- GNS-3545-P101
- Status last verified
- Jul 2026
- First submitted
- 28 Oct 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, it is not planned that any IPD information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-effect Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GNS-3545 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07225296
- Acronym / sponsor ID
- GNS-3545-P101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Genosco Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Nov 2025 (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.
This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one cohort in Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a first-in-human, single ascending dose (SAD, Part 1) and multiple ascending dose (MAD, Part 2) study of orally administered GNS-3545 in healthy adults. Each cohort will include 8 participants (6 active, 2 placebo). In Part 1, a single oral dose will be administered under fasting conditions. In Part 2, once-daily dosing will be administered for 14 consecutive days under fasting conditions. Sequential cohorts will receive increasing doses, with dose escalation decisions based on safety and tolerability reviews by the Safety Review Committee (SRC). Six (6) cohorts (S1 to S6) are planned for evaluation in Part 1 (SAD), and Three (3) cohorts (M1 to M3) are planned for evaluation in Part 2 (MAD).
| Arm | Type | Receives |
|---|---|---|
| GNS-3545 | Experimental | Drug: GNS-3545Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo. Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo. |
| GNS-3545 Placebo | Placebo comparator | Drug: GNS-3545 PlaceboPart 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo. Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age
- Male subjects must follow protocol specified contraception guidance
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit and body weight of ≥ 50 kg
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee
Key exclusion criteria (19 listed)
- Is mentally or legally incapacitated or has significant emotional problems
- History or presence of clinically significant medical or psychiatric conditions
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Surgical procedure or Administration of a live vaccination within 30 days prior to the first dose of the study drug
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
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 |
|---|---|---|
| GNS-3545GNS-3545 will be administered as oral tablets at assigned dose levels to six of the eight participants within each cohort in Part 1 (SAD) and Part 2 (MAD). In Part 1, participants will receive a single dose on one occasion (Day 1). In Part 2, participants will receive daily dosing for 14 consecutive days. | Drug | GNS-3545 |
| GNS-3545 PlaceboThe placebo will be administered as oral tablets identical in appearance to the GNS-3545 tablets to two of the eight participants within each cohort in Part 1 (SAD) and Part 2 (MAD). In Part 1, participants will receive a single placebo dose on one occasion (Day 1). In Part 2, participants will receive once-daily placebo doses for 14 consecutive days. | Drug | GNS-3545 Placebo |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: Collection of TEAEs occurs from the point of first dose administration (Day 1 in each part) through to study completion (up to 8 days from the first dosing for Part 1 & up to 8 days from the last dosing for Part 2).
Number and severity of treatment-emergent adverse events (TEAEs) following single and multiple doses of GNS-3545 and placebo
6 secondary outcomes
Area under the time-concentration curve (AUC) from zero (pre-dose) to 24 hours (h) post-dose sample [0-24 h])
Time frame: Up to 4 days from the last dosing for Part 1 (SAD), Up to 4 days from the last dosing for Food Effect Cohort (Part 1), Up to 17 days from the last dosing for Part 2 (MAD)
Area under the time-concentration curve (AUC) from zero (pre-dose) to the time of the last measurable concentration (t) [0-t])
Time frame: Up to 4 days from the last dosing for Part 1 (SAD), Up to 4 days from the last dosing for Food Effect Cohort (Part 1), Up to 17 days from the last dosing for Part 2 (MAD)
Maximum observed concentration (Cmax) after a single dose and at steady state (Cmax,ss)
Time frame: Cmax for up to 4 days from the last dosing for Part 1 (SAD), Cmax for up to 4 days from the last dosing for Food Effect Cohort (Part 1), Cmax & Cmax,ss up to 17 days from the last dosing for Part 2 (MAD)
Time to reach maximum observed concentration (Tmax) after a single dose and at steady state (Tmax,ss)
Time frame: Tmax up to 4 days from the last dosing for Part 1 (SAD), Tmax for up to 4 days from the last dosing for Food Effect Cohort (Part 1), Tmax & Tmax,ss up to 17 days from the last dosing for Part 2 (MAD)
Cumulative amount excreted in urine over the collection interval (CumAe) after a single dose and at steady state (CumAe,ss)
Time frame: CumAe for up to 4 days from the last dosing for Part 1 (SAD), CumAe,ss up to 17 days from the last dosing for Part 2 (MAD)
Lag time before the first measurable concentration (Tlag)
Time frame: Up to 4 days from the last dosing for Food Effect Cohort Only (Part 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No. At this stage, it is not planned that any IPD information will be shared.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruitingPhase 3
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 GNS-3545 in people with Idiopathic Pulmonary Fibrosis, run by Genosco Inc. 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 17 Jul 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: Collection of TEAEs occurs from the point of first dose administration (Day 1 in each part) through to study completion (up to 8 days from the first dosing for Part 1 & up to 8 days from the last dosing for Part 2).). 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 17 Jul 2026.