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 (NAVIGATE-2)

NCT07225959 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	400
Start date	2025-10-29
Completion	2027-07

Conditions

• Healthy Participants

Interventions

• CD388 Injection

Primary outcomes

• Occurrence of Anti-Drug Antibodies (ADAs) in Participants Administered CD388 — On Day 1 (pre-dose baseline), Day 29, Day 85, Day 169, and Day 197 in Study Period 1; on Day 1 (pre-dose), Day 29, Day 85, Day 169, and Day 197/End of Study (EOS) in Study Period 2
  Evaluation of blood serum samples for the occurrence of treatment-emergent anti-drug antibodies (ADAs) or treatment-boosted ADAs (based on an increase in ADA titer in samples positive for ADA at baseline) directed to CD388 in participants following administration of each annual dose of CD388.

Countries

United States, United Kingdom