New lung drug takes first step: safety check in healthy people
NCT ID NCT07225296
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This early-stage study tests a new medicine called GNS-3545 in 72 healthy adults to see if it is safe and how the body processes it. The drug is being developed for idiopathic pulmonary fibrosis, a disease that causes lung scarring. Participants will receive either the drug or a placebo, and researchers will monitor side effects and drug levels in the blood.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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63 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pharmaron CPC, Inc.
Baltimore, Maryland, 21201, United States
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Other studies related to the condition(s) this trial covers.
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