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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: Active Phase 2 study of Healthy Participants, sponsored by Cidara Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants are evaluated for the occurrence of treatment-induced ADAs following administration of each annual dose of MK-1406.
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 |
What the registry record for NCT07225959 still lists
NCT07225959 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 62-participant average among 119 other Healthy Participants trials with a reported enrollment target (545% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Participants
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07225959's enrollment target sits among peer trials
400 1st of 119 the highest 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.
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