Healthy VolunteerPhase 1NCT05298787
A Phase 1 SAD/MAD Study of RLS-0071 in Healthy Volunteers in Support of a COVID-19 Development Program
A Phase 1 study testing RLS-0071 in people with Healthy Volunteer, run by ReAlta Life Sciences, Inc. at 1 site in Canada.
Trial summary
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety, tolerability, PK, and PD of single- and multiple-ascending doses of RLS-0071 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RLS-0071
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2021to 16 Aug 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 60 years, inclusive, at the time of Screening.
- A female study subject must meet one of the following criteria: If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study intervention, during the study, and for at least 30 days after the last dose of the study intervention.
- An acceptable method of contraception includes one of the following: i. Abstinence from heterosexual intercourse ii. Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) iii. Intrauterine device (with or without hormones) -OR- b. Agrees to use a double barrier method (eg, condom and spermicide) during the study and for at least 30 days after the last dose of the study intervention Female subjects who are not of childbearing potential are exempt from contraceptive requirements. To be considered of nonchildbearing potential female subjects must meet the following requirements: Must be surgically sterile (documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy at least 3 months prior to Day 1) or postmenopausal (defined as 12 months from the time of last spontaneous menses). If necessary, a follicle-stimulating hormone (FSH) level > 35 IU/L at Screening will be considered confirmatory in the absence of a clear postmenopausal history.
- A male study subject who engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (eg, condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study intervention.
- Medically healthy on the basis of medical history, physical examination, and clinical laboratory testing in the opinion of the Investigator or designee.
- Nonsmokers and nonusers of nicotine-containing products, including e-cigarettes, for at least 6 continuous months before the first dose of study intervention and for the duration of the study, to be confirmed by cotinine testing at Screening.
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- Negative drug/alcohol testing at Screening and Check-in (Day -1).
- Vital signs (after semirecumbent for at least 5 minutes) that are within the following ranges at Screening and Check-in (Day -1):
- Systolic blood pressure (BP), 90 to 140 mmHg, inclusive
- Diastolic BP, 50 to 90 mmHg, inclusive
- Heart rate (HR), > 45 to ≤ 100 bpm
- Weight ≤ 90 kg and body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 at Screening.
- Normal renal function, defined as estimated creatinine clearance (CrCl) > 90 mL/min (calculated using the Modification of Diet in Renal Disease [MDRD] formula) 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 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, St John's Wort, milk thistle), or supplements/vitamins within 14 days before dosing with study intervention and for the duration of the study, with the exception of those approved by the Investigator and Sponsor (eg, oral contraceptives, hormone replacement therapy).
- Receipt of any investigational agent or treatment within 30 days or 5 half-lives, whichever is longer, prior to Screening.
- Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or monoclonal antibodies) within 3 months before dosing with study intervention.
- Note: Influenza and COVID-19 vaccine will be allowed if all doses in the regimen have been administered more than 21 days before dosing with study intervention.
- History of any major surgery within 6 months before dosing with study intervention.
- History of hepatic disease, or current clinically significant liver function test results, defined as alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin and fractionated bilirubin, and alkaline phosphatase (AP) > 1.5 × upper limit of normal (ULN) at Screening.
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- 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.
- Diagnosis or positive Screening test for antinuclear antibodies (ANA), anti-double-stranded deoxyribonucleic acid (DNA) antibodies (anti-dsDNA), anti-ribonucleoprotein antibodies (anti-RNP), anti-Sjögren's syndrome type A antibodies (anti-Ro/SSA), anti-Sjögren's syndrome type B antibodies (anti-La/SSB), anti-Smith antibodies (anti-SM), and anti-phospholipid antibodies.
- Subjects with a history of autoimmune disease, glomerulonephritis, or vasculitis.
- Known history of allergy to any component of study intervention including polyethylene glycol (PEG).
- History of any active infection within 14 days dosing with study intervention, if deemed clinically significant by the Investigator and Sponsor.
- Any acute illness within 30 days before dosing with study intervention.
- History of warfarin use or International Normalized Ratio (INR) ≥ 1.5.
- Has a history (within 2 years before the first dose of study intervention) of moderate or severe use disorder for any substance other than caffeine (based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM-5] criteria).
- Diagnosis of or positive Screening result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV)-1 or HIV-2.
- Positive COVID-19 test or any prior COVID-19 diagnosis.
- 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 electrocardiogram (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, as follows:
- QTcF > 450 msec for males and > 470 msec for females or low, or flat T-waves making measurement of the interval unreliable at Screening or check-in (Day -1)
- Other ECG abnormalities considered clinically relevant in the judgment of the Investigator
- Concurrent conditions that could interfere with safety and/or tolerability measurements, as determined by the Investigator or a designee.
- Pregnant and/or lactating.
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
- Plasma donation within 7 days of Screening.
- Inability to tolerate IV administration.
- Poor venous access, as determined by the Investigator or a designee.
- Unable or unwilling to cooperate with the site staff for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD/MAD Adaptive-Design Study to Assess the Safety, Tolerability, PK, and PD of RLS-0071 in Healthy Adult Subjects in Support of a COVID-19 Development Program
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety, tolerability, PK, and PD of single- and multiple-ascending doses of RLS-0071 in healthy adult subjects.
Read the detailed description
The present study is a single-ascending dose (SAD) and multiple-ascending dose (MAD) evaluation of RLS-0071 in healthy volunteers. This study is designed to evaluate the safety and tolerability of RLS-0071 administered by the intravenous (IV) route to healthy subjects as single- and multiple-ascending doses. Importantly, a SAD/MAD study in healthy subjects is critical to generate robust pharmacokinetic (PK) data using intensified PK sample collection, not feasible in a patient study.
- Conditions
- Healthy Volunteer
- Being tested
- RLS-0071, Saline Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLS-0071Drug
RLS-0071 is administered as an IV infusion
Saline PlaceboDrug
Placebo is administered as an IV infusion
| Study group | Role | What they receive |
|---|---|---|
| SAD - 2mg/kg or placebo IV infusion | Experimental | Single IV infusion Receives: Drug: RLS-0071; Drug: Saline Placebo |
| SAD - 10mg/kg or placebo IV infusion | Experimental | Single IV infusion Receives: Drug: RLS-0071; Drug: Saline Placebo |
| SAD - 40mg/kg or placebo IV infusion | Experimental | Single IV infusion Receives: Drug: RLS-0071; Drug: Saline Placebo |
| MAD - 2mg/kg or placebo IV infusion | Experimental | IV infusion given every 8 hours over 3 days for a total of 9 doses Receives: Drug: RLS-0071; Drug: Saline Placebo |
| MAD - 10mg/kg or placebo IV infusion | Experimental | IV infusion given every 8 hours over 3 days for a total of 9 doses Receives: Drug: RLS-0071; Drug: Saline Placebo |
| SAD - 120mg/kg or placebo IV infusion | Experimental | Single IV infusion Receives: Drug: RLS-0071; Drug: Saline Placebo |
| MAD - 40mg/kg or placebo IV infusion | Experimental | IV infusion given every 8 hours over 3 days for a total of 9 doses Receives: Drug: RLS-0071; Drug: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Safety and tolerability will be assessed throughout the study by monitoring and evaluating TEAEs, including any complications resulting from the IV infusion. All AEs will be collected from the start of study intervention administration through Day 30 or Early Termination (ET). Adverse event grading will be defined by the CTCAE (latest version).
Measured: From initiation of study treatment (Day 1) through follow-up period (Day 30)
Incidence of abnormal laboratory test results
Measured: From initiation of study treatment (Day 1) through follow-up period (Day 30)
Secondary outcomes (6)
Plasma maximum measured drug concentration (Cmax)
Measured: 0 - 1 week
Time of maximum concentration (Tmax)
Measured: 0 - 1 week
Area under the concentration-time curve (AUC)
Measured: 0 - 1 week
Terminal elimination half-life (T 1/2)
Measured: 0 - 1 week
Pharmacodynamic parameter - mCH50 assay
mCH50 assay for detection of inhibition of classical complement pathway activation
Measured: 0 - 1 week
Pharmacodynamic parameter - C1q levels
Measured: 0 - 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start13 Jan 2021
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Each cohort will include 8 subjects randomized to receive either RLS-0071 (6 subjects) or placebo (2 subjects). Up to 7 cohorts (4 single-ascending dose \[SAD\] and 3 multiple-ascending dose \[MAD\]) enrolling up to 56 subjects are planned for the study. Subjects enrolled in a SAD cohort will receive a single infusion of RLS-0071. Subjects enrolled in a MAD cohort will receive a RLS-0071 infusion every (q) 8 hours for a total of 9 doses, with the ninth infusion occurring in the morning on Day 4. Dose escalation will depend on the Safety Review Committee (SRC) review of available blinded safety and PK data through the observation period of the previous cohort (ie, 48 hours after the last dose of study intervention).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReAlta Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenji Cunnion, MD, Study director, Chief Medical Officer, ReAlta Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298787
- Sponsor's protocol ID
- RLS-0071-101
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 28 Mar 2022
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD/MAD Adaptive-Design Study to Assess the Safety, Tolerability, PK, and PD of RLS-0071 in Healthy Adult Subjects in Support of a COVID-19 Development Program
- ClinicalTrials.gov ID
- NCT05298787
- Acronym / sponsor ID
- RLS-0071-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ReAlta Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 28 Mar 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 1, single-center, randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety, tolerability, PK, and PD of single- and multiple-ascending doses of RLS-0071 in healthy adult subjects.
Detailed description
The present study is a single-ascending dose (SAD) and multiple-ascending dose (MAD) evaluation of RLS-0071 in healthy volunteers. This study is designed to evaluate the safety and tolerability of RLS-0071 administered by the intravenous (IV) route to healthy subjects as single- and multiple-ascending doses. Importantly, a SAD/MAD study in healthy subjects is critical to generate robust pharmacokinetic (PK) data using intensified PK sample collection, not feasible in a patient study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Each cohort will include 8 subjects randomized to receive either RLS-0071 (6 subjects) or placebo (2 subjects). Up to 7 cohorts (4 single-ascending dose [SAD] and 3 multiple-ascending dose [MAD]) enrolling up to 56 subjects are planned for the study. Subjects enrolled in a SAD cohort will receive a single infusion of RLS-0071. Subjects enrolled in a MAD cohort will receive a RLS-0071 infusion every (q) 8 hours for a total of 9 doses, with the ninth infusion occurring in the morning on Day 4. Dose escalation will depend on the Safety Review Committee (SRC) review of available blinded safety and PK data through the observation period of the previous cohort (ie, 48 hours after the last dose of study intervention).
| Arm | Type | Receives |
|---|---|---|
| SAD - 2mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboSingle IV infusion |
| SAD - 10mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboSingle IV infusion |
| SAD - 40mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboSingle IV infusion |
| MAD - 2mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboIV infusion given every 8 hours over 3 days for a total of 9 doses |
| MAD - 10mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboIV infusion given every 8 hours over 3 days for a total of 9 doses |
| SAD - 120mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboSingle IV infusion |
| MAD - 40mg/kg or placebo IV infusion | Experimental | Drug: RLS-0071, Drug: Saline PlaceboIV infusion given every 8 hours over 3 days for a total of 9 doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age 18 to 60 years, inclusive, at the time of Screening.
- A female study subject must meet one of the following criteria: If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study intervention, during the study, and for at least 30 days after the last dose of the study intervention.
- A male study subject who engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (eg, condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study intervention.
- Medically healthy on the basis of medical history, physical examination, and clinical laboratory testing in the opinion of the Investigator or designee.
- Nonsmokers and nonusers of nicotine-containing products, including e-cigarettes, for at least 6 continuous months before the first dose of study intervention and for the duration of the study, to be confirmed by cotinine testing at Screening.
Key exclusion criteria (29 listed)
- Use of any prescription or over-the-counter (OTC) medications, herbal products (eg, St John's Wort, milk thistle), or supplements/vitamins within 14 days before dosing with study intervention and for the duration of the study, with the exception of those approved by the Investigator and Sponsor (eg, oral contraceptives, hormone replacement therapy).
- Receipt of any investigational agent or treatment within 30 days or 5 half-lives, whichever is longer, prior to Screening.
- Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or monoclonal antibodies) within 3 months before dosing with study intervention.
- Note: Influenza and COVID-19 vaccine will be allowed if all doses in the regimen have been administered more than 21 days before dosing with study intervention.
- History of any major surgery within 6 months before dosing with study intervention.
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-0071RLS-0071 is administered as an IV infusion | Drug | MAD - 10mg/kg or placebo IV infusion, MAD - 2mg/kg or placebo IV infusion, MAD - 40mg/kg or placebo IV infusion, SAD - 10mg/kg or placebo IV infusion, SAD - 120mg/kg or placebo IV infusion, SAD - 2mg/kg or placebo IV infusion, SAD - 40mg/kg or placebo IV infusion |
| Saline PlaceboPlacebo is administered as an IV infusion | Drug | MAD - 10mg/kg or placebo IV infusion, MAD - 2mg/kg or placebo IV infusion, MAD - 40mg/kg or placebo IV infusion, SAD - 10mg/kg or placebo IV infusion, SAD - 120mg/kg or placebo IV infusion, SAD - 2mg/kg or placebo IV infusion, SAD - 40mg/kg or placebo IV infusion |
Primary outcome
Incidence of adverse events
Time frame: From initiation of study treatment (Day 1) through follow-up period (Day 30)
Safety and tolerability will be assessed throughout the study by monitoring and evaluating TEAEs, including any complications resulting from the IV infusion. All AEs will be collected from the start of study intervention administration through Day 30 or Early Termination (ET). Adverse event grading will be defined by the CTCAE (latest version).
Incidence of abnormal laboratory test results
Time frame: From initiation of study treatment (Day 1) through follow-up period (Day 30)
6 secondary outcomes
Plasma maximum measured drug concentration (Cmax)
Time frame: 0 - 1 week
Time of maximum concentration (Tmax)
Time frame: 0 - 1 week
Area under the concentration-time curve (AUC)
Time frame: 0 - 1 week
Terminal elimination half-life (T 1/2)
Time frame: 0 - 1 week
Pharmacodynamic parameter - mCH50 assay
Time frame: 0 - 1 week
Pharmacodynamic parameter - C1q levels
Time frame: 0 - 1 week
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 28 Mar 2022.
- Individual participant dataSharing planned: No
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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 study director
Chief Medical Officer, 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 in people with Healthy Volunteer, run by ReAlta Life Sciences, Inc. at 1 site in Canada.
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 15 inclusion and 29 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 28 Mar 2022. 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 Canada. 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?
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?
Incidence of adverse events (time frame: From initiation of study treatment (Day 1) through follow-up period (Day 30)). The study lists 2 primary outcomes in all. 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 28 Mar 2022.