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New treatment option for Non-cystic Fibrosis Bronchiectasis
Official title A Clinical Study of RSS0343 in Healthy Subjects
ClinicalTrials.gov ID: NCT07289464
What this study is testing
What is RSS0343 Tablets?
RSS0343 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-cystic fibrosis bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- people who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.
- Healthy individuals aged 18 to 55 years, inclusive. Males and females
- Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height 2 (m²). BMI between 19 and 28 kg/m², inclusive.
- Fertile male and female people and their partners must agree to use highly effective contraception as stipulated in the protocol, from screening...
You likely can't join if
- people who smoked more than 5 cigarettes (or equivalent nicotine products) daily within 3 months prior to screening or intended to use tobacco...
- people with frequent alcohol consumption (\>15 g/day for females or \>25 g/day for males [5g of alcohol is equivalent to 150 mL of beer, 50 mL of...
- people with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.
- people who had donated blood or experienced a total blood loss of ≥200 mL within 1 month, or ≥400 mL within 3 months prior to dosing, or who had...
- people with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.
- people deemed by the investigators to be unsuitable for the trial for any other reason.
See the full eligibility criteria
- people who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.
- Healthy individuals aged 18 to 55 years, inclusive. Males and females
- Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height 2 (m²). BMI between 19 and 28 kg/m², inclusive.
- Fertile male and female people and their partners must agree to use highly effective contraception as stipulated in the protocol, from screening until 6 months (for females) or 3 months (for males) after the last dose...
- people who smoked more than 5 cigarettes (or equivalent nicotine products) daily within 3 months prior to screening or intended to use tobacco products during the trial.
- people with frequent alcohol consumption (\>15 g/day for females or \>25 g/day for males [5g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or approximately 17 mL of low-alcohol liquor], on more than 2...
- people with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.
- people who had donated blood or experienced a total blood loss of ≥200 mL within 1 month, or ≥400 mL within 3 months prior to dosing, or who had received a blood transfusion within 8 weeks prior to dosing.
- people with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.
- people deemed by the investigators to be unsuitable for the trial for any other reason.
- people with any clinically significant abnormalities, as determined by the investigator, in physical examination, vital signs, laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation), chest...
- people who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
- people with a known or suspected allergy to the investigational drug or its excipients, or a history of severe allergic reactions (e.g., to drugs, food, toxins).
- people with any active autoimmune disease or immunodeficiency at screening.
- people with any history of severe clinical disease, or any condition that, in the investigator's judgment, could compromise trial outcomes, affect drug absorption, distribution, metabolism, or excretion...
- people who had undergone any surgery within 3 months prior to screening, had not fully recovered as determined by the investigator, or planned to undergo surgery during the trial or within 1 month after its completion.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.