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NCT07225959 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies Following Annual Doses of CD388
A Phase 2 study of Healthy Participants, sponsored by Cidara Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 3
- Study locations
NCT07225959 is a Phase 2 study of Healthy Participants that is active but no longer recruiting, run by Cidara Therapeutics. The registered enrollment target is 400 participants, above the 62-participant average among 119 other Healthy Participants trials with a reported enrollment target (545% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT07225959, a Phase 2 study of Healthy Participants, is active but no longer recruiting, sponsored by Cidara Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this clinical study is to learn if giving repeated annual doses of the experimental drug CD388 is safe and how the body reacts to it in healthy adults who have already received one dose without serious side effects. The study aims to determine if the body makes antibodies against CD388 after repeated doses, which might affect how the drug works or how safe it is, and to better understand the safety and tolerability of repeated doses. Participants will receive two doses of CD388 over two years and be monitored for 18 months. Researchers will check for immune responses against the drug, watch for any side effects, and measure how the drug behaves in the body over time. This study is based on the idea that people who tolerated CD388 well before will likely continue to tolerate it safely with repeated annual dosing, and that the risk of immune reactions will remain low. Expanded access to the study drug will not be provided to participants after the study ends.
Conditions Studied
Interventions
- COMBINATION_PRODUCT CD388 Injection
Study Locations (3)
Florida
- Floridian Clinical Research - Miami Lakes
South Carolina
- Spartanburg Medical Research - Spartanburg
England
- hVIVO Serviced Limited - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-10-29 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07225959
The ClinicalTrials.gov registry entry for NCT07225959 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 62-participant average among 119 other Healthy Participants trials with a reported enrollment target (545% higher). The listed sponsor is Cidara Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 1 intervention - of which CD388 Injection is the first listed.
NCT07225959 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, South Carolina, England.
Frequently Asked Questions
What is clinical trial NCT07225959 about?
NCT07225959 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies Following Annual Doses of CD388". The goal of this clinical study is to learn if giving repeated annual doses of the experimental drug CD388 is safe and how the body reacts to it in healthy adults who have already received one dose without serious side effects. The study aims to determine if the body makes antibodies against CD388 a...
What is the current status of trial NCT07225959?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2025-10-29. Estimated completion is 2027-07.
What conditions does trial NCT07225959 study?
This clinical trial studies the following conditions: Healthy Participants.
What interventions are being tested in trial NCT07225959?
The interventions under investigation include: CD388 Injection (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07225959?
This trial is sponsored by Cidara Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225959 being conducted?
This trial has 3 study locations across Florida, South Carolina, England. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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