Not Yet RecruitingPhase 1

A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection

China180 participantsStarted 2026-07-15

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants aged ≥18 to 49 years of age (Part 1) or
. Can understand the study procedures, voluntarily sign the informed consent form after informed consent.
. Able and willing to complete the study procedures during the entire study Follow-up period.
. Body temperature \< 37.0°C (Axillary temperature) on the day of enrollment (before vaccination).
. For all women of childbearing potential (WOCBP) females must use an effective contraceptive method from at least 2 weeks prior to study vaccination. All male and female subjects of childbearing potential agree to use a reliable method of contraception (Oral contraceptives (excluding emergency contraceptives), injectable or buried contraceptives, slow-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragm, cervical cap) until at least 6 months after study vaccination.

Exclusion criteria

. Previously received RSV vaccine or have participated or are currently participating in RSV vaccine clinical trials and have received the trial vaccine.
. A history of confirmed RSV infection or respiratory diseases related to RSV infection within 6 months prior to vaccination.
. Long term (defined as 14 days or more) treatment with immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination, or planned to receive such treatment within 30 days after vaccination, such as long-term use of systemic corticosteroids (continuous use for 2 weeks or more, dose ≥ 20mg/day prednisone or equivalent prednisone dose, excluding topical medications such as ointments, eye drops, inhalants, or nasal sprays);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events(AEs）

Timeframe: within 30 days after vaccination

Serious adverse events (SAEs)

Timeframe: within 12 months after vaccination

Heart rate in 12-lead electrocardiogram (ECG)

Timeframe: within 4 days after vaccination

PR interval in 12-lead electrocardiogram (ECG）

Timeframe: within 4 days after vaccination

RS duration in 12-lead electrocardiogram (ECG)

Timeframe: within 4 days after vaccination

QT/QTC in 12-lead electrocardiogram

Timeframe: within 4 days after vaccination

Trial details

NCT IDNCT07694557

SponsorBeijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Yuting Zhou

+86 18606417018 zhouyuting@bjykkc.com

View on ClinicalTrials.gov More Respiratory Syncytial Virus (RSV) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants aged ≥18 to 49 years of age (Part 1) or
. Can understand the study procedures, voluntarily sign the informed consent form after informed consent.
. Able and willing to complete the study procedures during the entire study Follow-up period.
. Body temperature \< 37.0°C (Axillary temperature) on the day of enrollment (before vaccination).
. For all women of childbearing potential (WOCBP) females must use an effective contraceptive method from at least 2 weeks prior to study vaccination. All male and female subjects of childbearing potential agree to use a reliable method of contraception (Oral contraceptives (excluding emergency contraceptives), injectable or buried contraceptives, slow-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragm, cervical cap) until at least 6 months after study vaccination.

Exclusion criteria

. Previously received RSV vaccine or have participated or are currently participating in RSV vaccine clinical trials and have received the trial vaccine.
. A history of confirmed RSV infection or respiratory diseases related to RSV infection within 6 months prior to vaccination.
. Long term (defined as 14 days or more) treatment with immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination, or planned to receive such treatment within 30 days after vaccination, such as long-term use of systemic corticosteroids (continuous use for 2 weeks or more, dose ≥ 20mg/day prednisone or equivalent prednisone dose, excluding topical medications such as ointments, eye drops, inhalants, or nasal sprays);

What they're measuring

Adverse events(AEs）

Timeframe: within 30 days after vaccination

Serious adverse events (SAEs)

Timeframe: within 12 months after vaccination

Heart rate in 12-lead electrocardiogram (ECG)

Timeframe: within 4 days after vaccination

PR interval in 12-lead electrocardiogram (ECG）

Timeframe: within 4 days after vaccination

RS duration in 12-lead electrocardiogram (ECG)

Timeframe: within 4 days after vaccination

QT/QTC in 12-lead electrocardiogram

Timeframe: within 4 days after vaccination