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RNA Therapeutics

Olezarsen Dose Level 1 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 91 of treatment period 2
Awards & highlights

Study Summary

This trial assesses how well two different forms of a drug work when given to healthy adults at two different doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 91 of treatment period 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 91 of treatment period 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve (AUC) of olezarsen from time 0 to 336 hours (AUC0-336h)
Maximum plasma concentration of olezarsen (Cmax)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Olezarsen Dose Level 2Experimental Treatment1 Intervention
Participants will receive two doses of Dose Level 2 each, using one of the following two sequences: (i) AI on Day 1 of Treatment Period 1, followed by vial on Day 1 of Treatment Period 2; or (ii) vial on Day 1 of Treatment Period 1, followed by AI on Day 1 of Treatment Period 2 A washout period of at least 28 days will be maintained between the 2 treatment periods.
Group II: Olezarsen Dose Level 1Experimental Treatment1 Intervention
Participants will receive two doses of Dose Level 1 each, using one of the following two sequences: (i) AI on Day 1 of Treatment Period 1, followed by vial on Day 1 of Treatment Period 2; or (ii) vial on Day 1 of Treatment Period 1, followed by AI on Day 1 of Treatment Period 2. A washout period of 28-42 days will be maintained between the 2 treatment periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olezarsen
2022
Completed Phase 3
~330

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
146 Previous Clinical Trials
15,178 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I partake in this clinical experiment?

"This clinical trial is seeking 100 adults, aged 18-64, who meet the following conditions: signed informed consent and any legal authorizations, ability to comply with study protocols before receiving drug administration, communication proficiency with clinic personnel, non-smoking status for at least 6 months prior to first dose of medication taken. Additionally, female participants must be unable to conceive a child."

Answered by AI

What is the overall enrollment number for this clinical trial?

"Indeed, the information hosted on clinicaltrials.gov indicates that this investigation is currently searching for eligible candidates. This trial was initially uploaded onto the website October 5th 2022 and last edited November 29th 2022 - it requires a hundred individuals from 1 medical facility to participate."

Answered by AI

Are there any vacancies still available for individuals to participate in this trial?

"This trial is currently enrolling volunteers, with the initial posting on October 5th 2022 and most recent modifications occuring November 29th of the same year."

Answered by AI

Is eligibility limited to those under 45 years of age for this clinical experiment?

"To qualify for this trial, applicants must be between 18 to 64 years old. There are 50 trials available for minors and 371 studies open to seniors aged 65 or above."

Answered by AI

Has Olezarsen Dose Level 2 received authorization from the FDA?

"Our team has assigned Olezarsen Dose Level 2 a score of 1, as this is an early-stage trial with limited evidence for both safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants
2022. "A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579860.
~42 spots leftby Apr 2025
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