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NCT07300085 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine
A Phase 1 study of Healthy Participants, sponsored by Cidara Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT07300085: Recruiting Phase 1 study of Healthy Participants, sponsored by Cidara Therapeutics.
NCT07300085 is a Phase 1 study of Healthy Participants that is actively recruiting participants, run by Cidara Therapeutics. The registered enrollment target is 100 participants, above the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (54% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07300085, a Phase 1 study of Healthy Participants, is actively recruiting participants, sponsored by Cidara Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical study is to investigate how safe and effective it is to receive both the Fluzone® High-Dose (HD) influenza vaccine and CD388, a long-acting antiviral medicine, at the same time. Some participants will receive the vaccine and CD388, while others will receive the vaccine and a placebo. The study aims to determine whether taking CD388 together with the flu vaccine affects the body's ability to build protection-called an immune response-against the flu, as compared to getting the vaccine with a placebo. The hypothesis is that giving both at the same time does not weaken the immune response to the vaccine. The study will measure the amount of antibodies (proteins produced by the immune system to fight flu viruses) generated by participants in both groups to check that CD388 does not interfere with how well the vaccine works. Participants will also be closely watched for any side effects or reactions to check that CD388 is safe to take alongside the vaccine. Expanded access to the study treatments (flu vaccine and CD388) will not be provided to participants after the study ends.
Primary Outcome
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- BIOLOGICAL Fluzone HD influenza vaccine
- COMBINATION_PRODUCT CD388 Injection
Study Locations (2)
California
- California Clinical Trials Medical Group (CCTMG) managed by Parexel - Glendale
Maryland
- Parexel International - EPCU Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-11-08 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What NCT07300085 shows while recruiting
NCT07300085 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (54% higher).
The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT07300085 reports a single indexed study location in California, Maryland.
Frequently Asked Questions
What is clinical trial NCT07300085 about?
NCT07300085 is a clinical study titled "A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine". The goal of this clinical study is to investigate how safe and effective it is to receive both the Fluzone® High-Dose (HD) influenza vaccine and CD388, a long-acting antiviral medicine, at the same time. Some participants will receive the vaccine and CD388, while others will receive the vaccine and ...
What is the current status of trial NCT07300085?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-11-08. Estimated completion is 2026-05.
What conditions does trial NCT07300085 study?
This clinical trial studies the following conditions: Healthy Participants.
What interventions are being tested in trial NCT07300085?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Fluzone HD influenza vaccine (BIOLOGICAL), CD388 Injection (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07300085?
This trial is sponsored by Cidara Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07300085 being conducted?
This trial has 2 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07300085's enrollment target sits among peer trials
100 22nd of 119 higher than 96 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants 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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