Healthy VolunteersPhase 1NCT04731623
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904
A Phase 1 study testing ION904 in people with Healthy Volunteers, run by Ionis Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to assess the safety and tolerability of ION904. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ION904
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2021to 11 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be healthy males, or females of non-childbearing potential, aged 18 to 65 at the time of informed consent
- Females must be either surgically sterile or post-menopausal; males must be abstinent, surgically sterile, or if engaged in sexual relations with a woman of childbearing potential, a highly effective contraceptive method must be used from the time of signing the informed consent form until at least 13 weeks after the last dose of Study Drug or the healthy participant must be abstinent through this time period
- Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 24 hours prior to study visits
- Body mass index (BMI) requirements between 18 and 35 kg/m^2
Who cannot join
- Clinically significant abnormalities in medical history or physical examination
- Uncontrolled arterial hypertension
- Active infection with human immunodeficiency virus (HIV), hepatitis C or hepatitis B or prior treatment for hepatitis C
- Treatment with another investigational drug, biological agent, or device within 1 month of Screening
- History of bleeding diathesis or coagulopathy
- Regular use of alcohol within 6 months prior to screening, or use of soft drugs within 3 months prior to Screening, or hard drugs within 1 year prior to Screening, or positive urine drug screen at Screening
Show all 13Show fewer
- History of any severe (e.g., anaphylaxis) drug allergies
- History of hypersensitivity to other antisense oligonucleotides (ASOs)
- Concomitant medication restrictions: over-the-counter or prescription medications within 14 days, prior to dosing on Day 1. Accepted exceptions are:
- Acetaminophen (paracetamol) up to 2 grams per day (g/d) or ibuprofen up to 2.4 g/day taken sporadically for analgesia
- Thyroid hormone replacement therapy provided participant is stable on replacement therapy (and participant is euthyroid)
- Other possible exceptions must be reviewed and acknowledged by the Investigator in consultation with Sponsor's Medical Monitor
- Blood donation of 50 to 499 mL within 30 days of Screening or of > 499 mL within 60 days of Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending, Dose-Escalation, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904 Administered Subcutaneously to Healthy Participants
The purpose of this study is to assess the safety and tolerability of ION904.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study of ION904 in up to 72 participants. Following a Screening Period of up to 28 days, eligible healthy participants will be randomized to treatment and receive a single, subcutaneous (SC) dose of the assigned study drug. Participants will be followed for up to 13 weeks after dosing.
- Conditions
- Healthy Volunteers
- Being tested
- ION904, Placebo
- Keywords
- Healthy Participants, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ION904Drug
ION904 will be administered by SC injection.
PlaceboDrug
Placebo (0.9% sterile saline) will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| ION904 | Experimental | Single ascending dose of ION904 will be administered by SC injection on Day 1. Receives: Drug: ION904 |
| Placebo | Placebo comparator | Placebo (0.9% sterile saline) will be administered by SC injection on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Measured: Up to Day 85
Severity and dose relationship of TEAE
Measured: Up to Day 85
Severity and dose relationship of clinically significant changes in laboratory values
Measured: Up to Day 85
Severity and dose relationship of clinically significant changes in ECG
Measured: Up to Day 85
Secondary outcomes (6)
Changes in the Level of ION904 Target Biomarker
Measured: Up to Day 85
Cmax: Maximum Observed Plasma Concentration of ION904
Measured: Up to Day 85
Tmax: Time to Reach the Maximum Plasma Concentration of ION904
Measured: Up to Day 85
t½λz: Plasma Elimination Half-life of ION904
Measured: Up to Day 85
AUC0-t: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t for ION904
Measured: Up to Day 85
Urine 0-24 Hour (hr) Excretion of ION904
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start26 Feb 2021
- Primary completion12 Aug 2021
- Study completion11 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731623
- Sponsor's protocol ID
- ION904-CS1
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2021
- Last updated
- 9 Aug 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending, Dose-Escalation, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904 Administered Subcutaneously to Healthy Participants
- ClinicalTrials.gov ID
- NCT04731623
- Acronym / sponsor ID
- ION904-CS1
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Participants, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 11 Sep 2021 (actual)
- First posted
- 1 Feb 2021 (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.
The purpose of this study is to assess the safety and tolerability of ION904.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study of ION904 in up to 72 participants. Following a Screening Period of up to 28 days, eligible healthy participants will be randomized to treatment and receive a single, subcutaneous (SC) dose of the assigned study drug. Participants will be followed for up to 13 weeks after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ION904 | Experimental | Drug: ION904Single ascending dose of ION904 will be administered by SC injection on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (0.9% sterile saline) will be administered by SC injection on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be healthy males, or females of non-childbearing potential, aged 18 to 65 at the time of informed consent
- Females must be either surgically sterile or post-menopausal; males must be abstinent, surgically sterile, or if engaged in sexual relations with a woman of childbearing potential, a highly effective contraceptive method must be used from the time of signing the informed consent form until at least 13 weeks after the last dose of Study Drug or the healthy participant must be abstinent through this time period
- Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 24 hours prior to study visits
- Body mass index (BMI) requirements between 18 and 35 kg/m^2
Key exclusion criteria (13 listed)
- Clinically significant abnormalities in medical history or physical examination
- Uncontrolled arterial hypertension
- Active infection with human immunodeficiency virus (HIV), hepatitis C or hepatitis B or prior treatment for hepatitis C
- Treatment with another investigational drug, biological agent, or device within 1 month of Screening
- History of bleeding diathesis or coagulopathy
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 |
|---|---|---|
| ION904ION904 will be administered by SC injection. | Drug | ION904 |
| PlaceboPlacebo (0.9% sterile saline) will be administered by SC injection. | Drug | Placebo |
Primary outcome
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to Day 85
Severity and dose relationship of TEAE
Time frame: Up to Day 85
Severity and dose relationship of clinically significant changes in laboratory values
Time frame: Up to Day 85
Severity and dose relationship of clinically significant changes in ECG
Time frame: Up to Day 85
6 secondary outcomes
Changes in the Level of ION904 Target Biomarker
Time frame: Up to Day 85
Cmax: Maximum Observed Plasma Concentration of ION904
Time frame: Up to Day 85
Tmax: Time to Reach the Maximum Plasma Concentration of ION904
Time frame: Up to Day 85
t½λz: Plasma Elimination Half-life of ION904
Time frame: Up to Day 85
AUC0-t: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t for ION904
Time frame: Up to Day 85
Urine 0-24 Hour (hr) Excretion of ION904
Time frame: Up to 24 hours
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 9 Aug 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 ION904 in people with Healthy Volunteers, run by Ionis Pharmaceuticals, 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 4 inclusion and 13 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 9 Aug 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. 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?
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) (time frame: Up to Day 85). The study lists 4 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 9 Aug 2022.