HealthyPhase 1NCT05351671
A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS
A Phase 1 study testing RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses) and RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses) in people with Healthy, run by ReAlta Life Sciences, Inc. at 1 site in Germany.
Trial summary
This is a Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability, pharmacodynamics (PK) and pharmacokinetics (PD) of RLS-0071 in healthy adult subjects after challenge with inhaled lipopolysaccharide (LPS). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses) and RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2022to 21 Sep 2022
- 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
- Age 18 to 55 years, inclusive, at the time of Screening
- Female subjects of childbearing potential must agree to use a highly effective contraceptive method from Screening until 30 days after the last investigational medicinal product (IMP) intake and have a negative pregnancy test at Screening (blood test). The following contraceptive measures can achieve a failure rate of less than 1% per year when used consistently and correctly and are considered highly effective measures:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral / intravaginal / transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral / injectable / implantable)
- intrauterine device
- intrauterine hormone-releasing system
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- bilateral tubal occlusion
- vasectomized partner (provided that the partner is the sole sexual partner of the woman of childbearing potential and has received medical assessment of the surgical success)
- sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment). Abstinence is only accepted as true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods and withdrawal] is not an acceptable method of contraception).
- Female subjects who are not of childbearing potential are exempt from contraceptive requirements. To be considered of non-childbearing potential female subjects must meet the following requirements: Must be permanently sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before first dosing with the investigational medicinal product) or postmenopausal (defined as no menses for 12 months without an alternative medical cause).
- A male study subject must agree to use a double barrier method (eg, condom and spermicide) during sexual contact with a pregnant woman or a woman of childbearing potential ,and agree to not donate sperm during the study and for at least 90 days after the last dose of the IMP
- Medically healthy on the basis of medical history, physical examination, and clinical laboratory testing in the opinion of the Investigator
- Nonsmokers and nonusers of nicotine-containing products, including vaping devices for at least 6 continuous months before the first dosing with the investigational medicinal product and for the duration of the study, to be confirmed by cotinine testing at Screening and a smoking history of < 5 pack years
- Negative alcohol testing at Screening and Day 1
- Negative cotinine and drug screen testing at Screening.
- Vital signs (after semi-recumbent for at least 5 minutes) that are within the following ranges at Screening:
- Systolic blood pressure (BP): 90 to 140 mmHg, inclusive
- Diastolic BP: 50 to 90 mmHg, inclusive
- HR: > 45 to ≤ 100 bpm
- Weight ≤ 100 kg and body mass index ≥ 18 and ≤ 32 kg/m2 at Screening
- Normal renal function, defined as estimated creatinine clearance > 90 mL/min at Screening; an Investigator can determine based on clinical judgment whether a lower clearance rate can be accepted based on the muscle composition of the subject
- Willing and able to understand the information on the nature, the scope, and the relevance of the clinical study, and to provide voluntary, written informed consent to participate in the study
- Able to communicate well with the Investigator and/or study site personnel and to comply with the requirements of the entire study
Who cannot join
- Use of any prescription or over-the-counter (OTC) medications, herbal products (eg, cannabidiol, St John's Wort, milk thistle), or supplements/vitamins within 14 days or 5 half-lives (whichever is longer) before first dosing with IMP and for the duration of the study, with the exception of those approved by the Investigator and Sponsor (eg, oral contraceptives, hormone replacement therapy, acetaminophen for pain relief).
- Receipt of any investigational agent or treatment within 30 days or 5 half-lives, whichever is longer, before first dosing with IMP, or concurrent participation in another clinical study.
- Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or monoclonal antibodies) within 3 months before first dosing with IMP.
- Note: Influenza and COVID-19 vaccines will be allowed if all doses in the regimen have been administered more than 21 days before first dosing with IMP.
- History of any major surgery within 6 months before first dosing with IMP.
- Prior diagnosis of COVID 19 within 90 days before first dosing with IMP.
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- History of hepatic disease, or current clinically significant liver function test results, defined as ALT, AST, total bilirubin and fractionated bilirubin, or alkaline phosphatase > 1.5 × upper limit of normal (ULN) at Screening.
- Note: Isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated, and direct bilirubin is < 35%.
- History of any clinically relevant or chronic psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, hematological, or gastrointestinal abnormality (eg, inflammatory bowel disease)
- History of severe allergic/anaphylactic reaction
- History of autoimmune disease including glomerulonephritis
- Known hypersensitivity to the active substance or to any of the excipients of each IMP including lipopolysaccharide (LPS) and polyethylene glycol (PEG)
- History of any active infection within 14 days before dosing with IMP, if deemed clinically significant by the Investigator and Sponsor
- Any acute illness within 30 days before dosing with IMP
- Lower respiratory tract infection within 3 months before first dosing with IMP
- History of warfarin use or International Normalized Ratio ≥ 1.5
- History (within 2 years before the first dosing with IMP) of moderate or severe use disorder for any substance other than caffeine (based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria)
- Known diagnosis or active infection with Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV)-1 or HIV-2
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of RLS-0071
- Presence of clinically significant ECG finding (confirmed upon repeat testing) that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- Concurrent conditions that could interfere with safety and/or tolerability measurements, as determined by the Investigator
- Pregnant and/or lactating
- Inability to produce sufficient amounts of induced sputum at baseline visit
- Inability to tolerate IV administration
- Poor venous access, as determined by the Investigator
- Unable or unwilling to cooperate with the study site staff for any reason
- Employees of the Sponsor or subjects who are employees or relatives of the Investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Hanover, 30625
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Assess the Safety, Tolerability, PD and PK of RLS-0071 in Healthy Adult Subjects After Challenge With Inhaled Lipopolysaccharide (LPS)
This is a Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability, pharmacodynamics (PK) and pharmacokinetics (PD) of RLS-0071 in healthy adult subjects after challenge with inhaled lipopolysaccharide (LPS).
Clinical data are required to determine the potential benefit of RLS-0071, a novel drug that specifically inhibits multiple inflammatory pathways, for the treatment of severe asthma. This study has been designed to evaluate the efficacy of IV administered RLS-0071 to reduce inflammation symptoms in healthy subjects challenged with inhaled LPS, a well-known agent that produces a safe and well-controlled inflammatory response in the lung. This is a critical proof-of-concept study and dose-optimization study for future studies in severe asthma patients.
A total of 48 healthy adult subjects are planned to be enrolled in this study. Subjects will be randomly allocated to either of the treatment arms (Arm A or Arm B) with RLS-0071 or the placebo arm (Arm C) in a 1:1:1 ratio. Subjects will either receive intravenous infusion of RLS-0071 at a lower dose every 8 hours for a total of 3 doses (Arm A), RLS-0071 at a higher dose every 8 hours for a total of 3 doses (Arm B) or placebo dosed every 8 hours for a total of 3 doses (Arm C). Each subject completing the study will be evaluated for up to a total of 7 days. Subjects will be permitted to participate in only 1 arm of the study. Subjects discontinuing the study before data was collected at 6 hours post LPS challenge will be considered dropouts and will be replaced.
Read the detailed description
The inclusion of a double-blind design allows a comparison between subjects receiving RLS-0071 and placebo subjects who are experiencing the same procedures and restrictions in an unbiased manner. The inclusion of a placebo control group will facilitate the distinction between efficacy signals and possible procedural/environmental events.
Eligibility criteria have been included to mitigate the risk to study subjects. Vulnerable populations such as children are excluded, as well as subjects whose medical history suggest a higher risk of experiencing adverse effects.
LPS inhalation is used in this study to be able to evaluate proof-of-concept efficacy of RLS-0071 in otherwise healthy subjects. Thus, PD assessments will be conducted to provide evidence of target engagement and guide the design of future severe asthma studies.
- Conditions
- Healthy
- Being tested
- RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses), RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses), Placebo (saline dosed every 8 hours for a total of 3 doses)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses)Drug
After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at 10 mg/kg every 8 hours for total of 3 doses.
RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses)Drug
After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at a loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses.
Placebo (saline dosed every 8 hours for a total of 3 doses)Drug
After challenge with inhaled LPS, subjects will receive IV infusion of placebo (saline) dosed every 8 hours for a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | RLS-0071 lower dose group Receives: Drug: RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses) |
| Arm B | Experimental | RLS-0071 higher dose group Receives: Drug: RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses) |
| Arm C | Placebo comparator | Placebo group Receives: Drug: Placebo (saline dosed every 8 hours for a total of 3 doses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in absolute neutrophil count in induced sputum
Primary PD
Measured: At 6 and 24 hours after inhaled lipopolysaccharide (LPS).
Secondary outcomes (1)
Change from Baseline in cytokines (Th1 and Th17) in induced sputum
Secondary PD
Measured: At 6 and 24 hours after inhaled LPS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start23 May 2022
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- Subjects will be randomly allocated to either of the treatment arms with RLS-0071 or the placebo arm in a 1:1:1 ratio. Subjects will be permitted to participate in only 1 arm of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReAlta Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Kenji Cunnion, MD, MPH, Study chair, ReAlta Life Sciences, Inc.Linda Dell, Study director, ReAlta Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351671
- Sponsor's protocol ID
- RLS-0071-103
- Other IDs
- 2021-006288-26
- Status last verified
- Mar 2023
- First submitted
- 14 Apr 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Assess the Safety, Tolerability, PD and PK of RLS-0071 in Healthy Adult Subjects After Challenge With Inhaled Lipopolysaccharide (LPS)
- ClinicalTrials.gov ID
- NCT05351671
- Acronym / sponsor ID
- RLS-0071-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ReAlta Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 23 May 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 28 Apr 2022 (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 Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability, pharmacodynamics (PK) and pharmacokinetics (PD) of RLS-0071 in healthy adult subjects after challenge with inhaled lipopolysaccharide (LPS).
Clinical data are required to determine the potential benefit of RLS-0071, a novel drug that specifically inhibits multiple inflammatory pathways, for the treatment of severe asthma. This study has been designed to evaluate the efficacy of IV administered RLS-0071 to reduce inflammation symptoms in healthy subjects challenged with inhaled LPS, a well-known agent that produces a safe and well-controlled inflammatory response in the lung. This is a critical proof-of-concept study and dose-optimization study for future studies in severe asthma patients.
A total of 48 healthy adult subjects are planned to be enrolled in this study. Subjects will be randomly allocated to either of the treatment arms (Arm A or Arm B) with RLS-0071 or the placebo arm (Arm C) in a 1:1:1 ratio. Subjects will either receive intravenous infusion of RLS-0071 at a lower dose every 8 hours for a total of 3 doses (Arm A), RLS-0071 at a higher dose every 8 hours for a total of 3 doses (Arm B) or placebo dosed every 8 hours for a total of 3 doses (Arm C). Each subject completing the study will be evaluated for up to a total of 7 days. Subjects will be permitted to participate in only 1 arm of the study. Subjects discontinuing the study before data was collected at 6 hours post LPS challenge will be considered dropouts and will be replaced.
Detailed description
The inclusion of a double-blind design allows a comparison between subjects receiving RLS-0071 and placebo subjects who are experiencing the same procedures and restrictions in an unbiased manner. The inclusion of a placebo control group will facilitate the distinction between efficacy signals and possible procedural/environmental events.
Eligibility criteria have been included to mitigate the risk to study subjects. Vulnerable populations such as children are excluded, as well as subjects whose medical history suggest a higher risk of experiencing adverse effects.
LPS inhalation is used in this study to be able to evaluate proof-of-concept efficacy of RLS-0071 in otherwise healthy subjects. Thus, PD assessments will be conducted to provide evidence of target engagement and guide the design of future severe asthma studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomly allocated to either of the treatment arms with RLS-0071 or the placebo arm in a 1:1:1 ratio. Subjects will be permitted to participate in only 1 arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses)RLS-0071 lower dose group |
| Arm B | Experimental | Drug: RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses)RLS-0071 higher dose group |
| Arm C | Placebo comparator | Drug: Placebo (saline dosed every 8 hours for a total of 3 doses)Placebo group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Age 18 to 55 years, inclusive, at the time of Screening
- Female subjects of childbearing potential must agree to use a highly effective contraceptive method from Screening until 30 days after the last investigational medicinal product (IMP) intake and have a negative pregnancy test at Screening (blood test). The following contraceptive measures can achieve a failure rate of less than 1% per year when used consistently and correctly and are considered highly effective measures:
- Female subjects who are not of childbearing potential are exempt from contraceptive requirements. To be considered of non-childbearing potential female subjects must meet the following requirements: Must be permanently sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before first dosing with the investigational medicinal product) or postmenopausal (defined as no menses for 12 months without an alternative medical cause).
- A male study subject must agree to use a double barrier method (eg, condom and spermicide) during sexual contact with a pregnant woman or a woman of childbearing potential ,and agree to not donate sperm during the study and for at least 90 days after the last dose of the IMP
- Medically healthy on the basis of medical history, physical examination, and clinical laboratory testing in the opinion of the Investigator
Key exclusion criteria (27 listed)
- Use of any prescription or over-the-counter (OTC) medications, herbal products (eg, cannabidiol, St John's Wort, milk thistle), or supplements/vitamins within 14 days or 5 half-lives (whichever is longer) before first dosing with IMP and for the duration of the study, with the exception of those approved by the Investigator and Sponsor (eg, oral contraceptives, hormone replacement therapy, acetaminophen for pain relief).
- Receipt of any investigational agent or treatment within 30 days or 5 half-lives, whichever is longer, before first dosing with IMP, or concurrent participation in another clinical study.
- Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or monoclonal antibodies) within 3 months before first dosing with IMP.
- Note: Influenza and COVID-19 vaccines will be allowed if all doses in the regimen have been administered more than 21 days before first dosing with IMP.
- History of any major surgery within 6 months before first dosing with IMP.
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 |
|---|---|---|
| RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses)After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at 10 mg/kg every 8 hours for total of 3 doses. | Drug | Arm A |
| RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses)After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at a loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses. | Drug | Arm B |
| Placebo (saline dosed every 8 hours for a total of 3 doses)After challenge with inhaled LPS, subjects will receive IV infusion of placebo (saline) dosed every 8 hours for a total of 3 doses. | Drug | Arm C |
Primary outcome
Change from Baseline in absolute neutrophil count in induced sputum
Time frame: At 6 and 24 hours after inhaled lipopolysaccharide (LPS).
Primary PD
1 secondary outcome
Change from Baseline in cytokines (Th1 and Th17) in induced sputum
Time frame: At 6 and 24 hours after inhaled LPS.
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 31 Mar 2023.
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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.
Kenji Cunnion, MD, MPH study chair
ReAlta Life Sciences, Inc.
Linda Dell study director
ReAlta Life Sciences, Inc.
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 RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses) and RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses) in people with Healthy, run by ReAlta Life Sciences, Inc. at 1 site in Germany.
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 23 inclusion and 27 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 31 Mar 2023. 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 Germany. 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?
Change from Baseline in absolute neutrophil count in induced sputum (time frame: At 6 and 24 hours after inhaled lipopolysaccharide (LPS).). 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 31 Mar 2023.