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ACTIVE NOT RECRUITING
NCT07225959
PHASE2

A Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies Following Annual Doses of CD388

Sponsor: Cidara Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Open-Label, Long-Term Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies in Healthy Participants Following Annual Doses of CD388, a Novel Long-Acting Antiviral Conjugate

Key Details

Gender

All

Age Range

18 Years - 66 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-10-29

Completion Date

2027-07

Last Updated

2025-12-26

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

CD388 Injection

CD388 liquid for injection

Locations (3)

Floridian Clinical Research

Miami Lakes, Florida, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

hVIVO Serviced Limited

London, England, United Kingdom