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 range18 Years – 55 Years

SexALL

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.

Timeframe: within 36 days after administration

Trial details

NCT IDNCT05933824

SponsorShanxi Kangbao Biological Product Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-12

View on ClinicalTrials.gov More Hiv trials

Who can participate

Age range18 Years – 55 Years

SexALL

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.

Timeframe: within 36 days after administration