NCT07225959

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 2, open-label, long-term study to evaluate the occurrence of anti-drug antibodies (ADAs) directed to CD388 during an 18-month period following administration of 2 annual doses of CD388 in healthy participants who previously completed study CD388.SQ.2.05, having received a dose of the active drug without experiencing any serious adverse event(s) (SAE\[s\]) during that study. This study will also evaluate the safety and tolerability of CD388 and the pharmacokinetics (PK) of CD388 following repeated annual dosing.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CD388 Injection	CD388 liquid for injection

Timeline

• Start date: 2025-10-29
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-11-10
• Last updated: 2025-12-26

Locations

3 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study