CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
CD388 Injection +1 morecombination
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Japanese descent with Japanese parents and grandparents
  • ✓Age 18-65 years inclusive
  • ✓Good health without signs or symptoms of current illness
  • ✓Creatinine clearance ≥80 mL/minute (Cockcroft-Gault)
Key exclusion· 9
  • ✕History of hypersensitivity to zanamivir, other neuraminidase inhibitors, or CD388 excipients; history of drug-induced exfoliative skin disorders (SJS, erythema multiforme, TEN)
  • ✕History of chronic immune-mediated disease or first-degree family history of autoimmune disease
  • ✕History of atopic dermatitis or psoriasis
  • ✕History of psychiatric condition, seizures, hallucinations, anxiety, depression, or mental health treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05619536
NCT05619536Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese Subjects

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Nov 17, 2022·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating CD388 Injection and Saline placebo for Healthy. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when dosed by subcutaneous (SQ) administration as a single dose to healthy Japanese adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsJanssen Pharmaceuticals

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedNov 17, 2022
Enrollment StartOct 18, 2022
Primary CompletionJul 14, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.6 years ago

Interventions

CD388 Injectioncombination

CD388 liquid for injection

Saline placebodrug

Sterile normal saline for injection