406P1

Phase 1

Completed

• Conditions: Prevention of Zika virus infection

• Registration Number: JPRN-jRCT2080224697
• Lead Sponsor: KM Biologics Co., Ltd.

Brief Summary

KD-406 was confirmed to be satisfactorily tolerable and immunogenically sound in healthy in healthy adult males and females aged >=20 years to <65 years after the second or third administration.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-24
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Healthy adult males and females aged >=20 years to <65 years (from the time of informed consent to the third administration of investigational product).
2) Those who are judged to be healthy adults qualified to participate in this clinical study by the principal investigator or sub-investigator as a result of the screening exam.
3) Those who have given written informed consent.

Exclusion Criteria

1) Those who had Zika virus infection, dengue virus infection, Japanese encephalitis, tick-borne encephalitis, or yellow fever (based on interview with subjects).
2) Those who had vaccination history of dengue vaccine, tick-borne encephalitis vaccine, or yellow fever vaccine (based on interview with subjects).
3) Those who have an obvious history of anaphylaxis caused by the components of the investigational products.
4) Pregnant women, women who may be pregnant, women who wish to become pregnant during the clinical trial period, women who are nursing
5) Those who have Fibrodysplasia Ossificans Progressiva (FOP).
6) Those who are determined not to be suitable as a subject of the clinical study by the principle investigator or sub-investigator for any other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified