Study to Evaluate the Safety, Tolerability, Pharmacokinet... | NCT05933824

NCT05933824

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Institute of Pathogen Biology, Beijing, China	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PartA:Dose level(5mg)	Experimental	Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.	Drug: LP-98 injection
PartA:Dose level(10mg)	Experimental	Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.	Drug: LP-98 injection
PartA:Dose level(20mg)	Experimental	Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.	Drug: LP-98 injection
PartA:Dose level(40mg)	Experimental	Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LP-98 injection	Drug	Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo	PartA:Dose level(10mg) PartA:Dose level(20mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline in respiration rate of Vital Signs	Respiration rate in times / minute	Within 36 days after the first administration.
Changes from baseline in blood pressure of Vital Signs.	Blood pressure in mmHg	Within 36 days after the first administration.
Changes from baseline in body temperature of Vital Signs.	Body temperature in Celsius degree	Within 36 days after the first administration.
Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads	Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.	within 36 days after administration
Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads	Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.	within 36 days after administration
Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads	Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.	within 36 days after administration
Changes from baseline in Blood lactate of Laboratory Examination.	Changes of blood lactate will be recorded.

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in Immunogenic blood collection of Laboratory Examination.	Changes of immunogenic blood collection will be recorded.The historical changes of test results (including positive rate and titer) of various indicators were counted.	within 36 days after administration
Pharmacokinetics：Cmax

Other Outcomes

Measure	Description	Time Frame
Explore changes in biomarkers (CD4+, CD8+T cell counts) from baseline after administration	Changes of CD4+T cell counts will be recorded.	within 36 days after administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria for study entry:

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;
Having positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody;
Having clinically significant abnormal results of vital signs or laboratory tests required by the protocol;
Having clinically significant abnormality of 12-lead ECG, or having a QTcF interval (using Fridericia's correction) > 450 ms for males or > 470 ms for females;
With serum creatine clearance rate (Ccr) < 80 ml/min/1.73 m2 (based on Cockcroft-Gault formula);
Known or suspected history of drug abuse (i.e., morphine, methamphetamine, ketamine, dimethylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine etc.), or having positive result for drug abuse;
With history of heavy alcohol consumption within 1 year prior to screening (more than 21 units of alcohol per week, i.e., 360 ml of 5% beer, 45 ml of 40% hard liquor, 120 ml of 12% wine, or positive alcohol test;
Smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to comply with the prohibition of smoking during the study;
Consuming amount > 6 servings of coffee, tea, cola, energy-drink, or other caffeine-containing product per day. One serving ≈ 120 mg of caffeine. Or consumed any caffeine-containing product within 24 hours prior to the dosing of the IP;
Had received vaccination within 30 days prior to screening, or planning to receive vaccination during the study;
Had received any prescription and non-prescription drugs, herbal remedies, or dietary supplements within 14 days prior to the dosing of the IP;
Participated in any other clinical trial within 3 months prior to screening;
Had received surgical operation within 3 months prior to screening, or planning to receive surgical operation during the study;
Currently pregnant or lactating women；
Had blood donation or blood loss over 200 mL within 3 months prior to screening, or planning to donate blood during the study；
Cannot tolerate venipuncture blood collection and/or have a history of blood or needle sickness
Other conditions considered to be ineligible for study entry in the PI's judgment

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections