CompletedPhase 1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects

China36 participantsStarted 2023-07-13

Plain-language summary

A randomized, placebo-controlled, single-administration, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of LP-98 injection in healthy subjects in a first-in-human clinical study

Who can participate

Age range

18 Years – 55 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

. Willing to participate in the study and sign ICF with clear date;
. Aged 18 to 55 years at the screening visit, male or female;
. Body weight ≥ 50 kg for males or body weight ≥ 45 kg for females, and body mass index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
. Be in good health in the PI's judgment, with no clinical significance in previous medical history, laboratory tests, physical examinations, vital signs, and ECG findings;
. All subjects and his/her partners must agree to use effective non-drug contraception (except for subjects had permanent contraception, i.e., bilateral tubal ligation or vasectomy, etc.) from 2 weeks prior to screening to 3 months after finishing the study. Females must have a negative serum human chorionic gonadotropin (hCG) test for pregnancy confirmation at screening;
. Willing to comply with the visits, treatments, laboratory tests and other study process required by the protocol.

Exclusion criteria

. Allergic to the IP or its excipients, or medicine of the same class , or having a history of severe allergies (including any food allergy or drug allergy);
. With history or family history of psychiatric, or history of chronic or serious disorders of the central nervous system, cardiovascular, hepatic, nephrological, pulmanory, digestive, metabolic, hematological or skeletal system etc., or definitive history of myelosuppression, orany other significant history of disease that may affect the safety or PK parameters in the PI's judgment;

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

Changes from baseline in respiration rate of Vital Signs

Timeframe: Within 36 days after the first administration.

Changes from baseline in blood pressure of Vital Signs.

Timeframe: Within 36 days after the first administration.

Changes from baseline in body temperature of Vital Signs.

Timeframe: Within 36 days after the first administration.

Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads

Timeframe: within 36 days after administration

Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads

Timeframe: within 36 days after administration

Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads

Timeframe: within 36 days after administration

Changes from baseline in Blood lactate of Laboratory Examination.

Trial details

NCT IDNCT05933824

SponsorShanxi Kangbao Biological Product Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-12

View on ClinicalTrials.gov More HIV (Human Immunodeficiency Virus) trials

Who can participate

Age range

18 Years – 55 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

. Willing to participate in the study and sign ICF with clear date;
. Aged 18 to 55 years at the screening visit, male or female;
. Body weight ≥ 50 kg for males or body weight ≥ 45 kg for females, and body mass index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
. Be in good health in the PI's judgment, with no clinical significance in previous medical history, laboratory tests, physical examinations, vital signs, and ECG findings;
. All subjects and his/her partners must agree to use effective non-drug contraception (except for subjects had permanent contraception, i.e., bilateral tubal ligation or vasectomy, etc.) from 2 weeks prior to screening to 3 months after finishing the study. Females must have a negative serum human chorionic gonadotropin (hCG) test for pregnancy confirmation at screening;
. Willing to comply with the visits, treatments, laboratory tests and other study process required by the protocol.

Exclusion criteria

. Allergic to the IP or its excipients, or medicine of the same class , or having a history of severe allergies (including any food allergy or drug allergy);
. With history or family history of psychiatric, or history of chronic or serious disorders of the central nervous system, cardiovascular, hepatic, nephrological, pulmanory, digestive, metabolic, hematological or skeletal system etc., or definitive history of myelosuppression, orany other significant history of disease that may affect the safety or PK parameters in the PI's judgment;

What they're measuring

Changes from baseline in respiration rate of Vital Signs

Timeframe: Within 36 days after the first administration.

Changes from baseline in blood pressure of Vital Signs.

Timeframe: Within 36 days after the first administration.

Changes from baseline in body temperature of Vital Signs.

Timeframe: Within 36 days after the first administration.

Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads

Timeframe: within 36 days after administration

Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads

Timeframe: within 36 days after administration

Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads

Timeframe: within 36 days after administration

Changes from baseline in Blood lactate of Laboratory Examination.