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NCT03325075 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
A Phase 1 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03325075: Completed Phase 1 study, sponsored by ModernaTX.
NCT03325075 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03325075, a Phase 1 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
Primary Outcome
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and a
Interventions
- OTHER Placebo
- BIOLOGICAL VAL-181388
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-07-19 |
| Est. Completion | 2019-03-19 |
| Phase | Phase 1 |
What the finished NCT03325075 record still lists
NCT03325075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03325075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03325075 about?
NCT03325075 is a clinical study titled "Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants". This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
What is the current status of trial NCT03325075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-07-19. Estimated completion is 2019-03-19.
What interventions are being tested in trial NCT03325075?
The interventions under investigation include: Placebo (OTHER), VAL-181388 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03325075?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03325075's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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