Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06965751
Brief Summary:
The goal of this clinical trial is to learn if a new drug called PDI204, developed for treating or preventing COVID-19, is safe and well-tolerated in healthy volunteers. This is a first-in-human study. The main questions it aims to answer are:
Is PDI204 safe and well-tolerated in healthy people? How long for and how does the body interact with PDI204?
Researchers will compare side effects in people who receive PDI204 and in those who receive a placebo (a look-alike substance that contains no drug) to see if and how many side-effects there are with PDI204. Researchers will also measure how long PDI204 can be detected in the blood.
Participants will be asked to receive a single dose of PDI204. Participants will have to stay in the clinical center for the day of receiving the dose of PDI204 and will be discharged the next day. Participants will then need to come back to the clinical center for study visits on days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7).
Detailed Description:
"A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) of PDI204 as Intravenous Infusion or Intramuscular Injection in Healthy participants" will be a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose (SAD) study evaluating the safety, tolerability, and pharmacokinetics (PK) of PDI204 via a single intravenous (IV) or intramuscular (IM) dose in healthy adult participants. The study will also assess the incidence and impact of antidrug antibodies (ADAs) on PK parameters and evaluate SARS-CoV-2 neutralizing antibody (NAb) levels over time. The study will consist of a single part with 4 cohorts: 3 sequential cohorts receiving IV administration (Cohorts 1-3) in an ascending dose manner, and one cohort receiving IM administration (Cohort 4), which may partially or fully overlap with the first 3 cohorts. Each cohort will include 8 participants (6 participants receiving the active drug and 2 participants receiving the placebo), for a total of 32 participants. The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day 1 and will be discharged on Day 2 following the completion of all required assessments. Participants will return to the clinical site for follow-up visits on Days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7). The total duration of study participation for each participant from screening through the study exit is anticipated to be approximately 118 days. A staggered dosing schedule will be used for dosing of each cohort and will include 2 sentinel participants (1 active and 1 placebo) dosed initially, and the remaining 6 participants dosed at least 24 hours later in Cohorts 1a, 2a and 3a (IV administration); and at least 48 hours later in Cohort 2b (IM administration). The planned dose range for IV administration (Cohorts 1-3) is anticipated to be from 200 to 1200 mg, while a single 300 mg dose is planned for IM administration (Cohort 4).Following completion of each dose level, a Safety Review Committee (SRC) will review the safety and tolerability data, as well as available PK data, in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose. Additionally, the SRC may extend the duration of the IV infusion (Cohorts 1-3) if necessary to improve participant safety or tolerability.
Study:
NCT06965751
Study Brief:
Protocol Section:
NCT06965751