Study of Safety, Pharmacokinetics & Anti-Drug Antibodies After Annual Doses of CD388
Research type
Research Study
Full 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
IRAS ID
1012942
Contact name
Joaquin Sosa
Contact email
Sponsor organisation
Cidara Therapeutics, Inc.
ISRCTN Number
ISRCTN20641445
Research summary
In this study, participants who were previously enrolled in Study CD388.SQ.2.05 and received a single dose of CD388, will receive two annual doses of CD388 450mg. for 2 years. The study will enrol generally healthy participants without disease. The minimum age for participation for males or females is 18 years old and maximum age is 66 years old. The study will be carried out in the US and UK. The total target participants across both countries is 400. The maximum duration for each participant will be 18 months (± 2 months). Participants will be required to attend 1 screening visit and then will attend day 1 which is the treatment visit, at the study site. Participants will be observed for at least 30 minutes before discharge. The first follow-up period includes study site visits on day 8, 29, 85, 169, 197 and 280. The second follow-up period includes study site visits on day 8, 29, 85, 169 and 197.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0349
Date of REC Opinion
13 Nov 2025
REC opinion
Further Information Favourable Opinion